Regulatory compliance director work from home jobs

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. Affirm's Compliance team designs and implements a compliance program that proactively addresses regulatory requirements while identifying and resolving potential issues. Compliance program activities include advisory, training, testing & monitoring, reporting, escalation, and oversight. Although a second line of defense, Compliance partners with the business to support new products and markets, change management, issue identification and remediation, and third-party assessment and monitoring. Compliance uses multiple data sources to enable informed decision-making, strengthen controls, and provide for better treatment of consumers. Affirm is seeking a Compliance Manager to own second-line advisory and independent oversight for Card, Deposits, and B2B Servicing. In this individual contributor role, you'll centralize and mature servicing compliance for these portfolios, embedding requirements in day-to-day operations, providing credible challenge, and driving durable fixes where gaps exist. You'll partner with Legal, Operations, Product, Engineering, and senior leadership to build and maintain policies, procedures, and control standards; strengthen risk-based monitoring and testing (including thoughtful automation); coordinate responses to audits/exams and bank-partner inquiries; and align servicing standards across consumer and small-business accounts. This role reports to the Director, Compliance and requires strong independent judgment and cross-functional influence. What You'll Do Provide the necessary leadership, expertise, and oversight to effectively manage Compliance efforts for servicing Affirm's products. Proactively monitor and translate regulatory developments into clear requirements and implementation plans. Identify compliance risks and vulnerabilities within servicing processes and systems. Assist the business with developing and implementing policies, procedures, and controls to ensure compliance with regulatory requirements during projects and BAU changes. Support timely, complete responses to audits, exams, bank-partner reviews, and regulatory inquiries. Collaborate with cross-functional teams to address compliance-related issues and drive continuous improvement initiatives. Review servicing changes via documented decision logs, approvals, and escalation paths. Leverage complaints and other signals to identify themes and drive durable product/process fixes. Deliver training and guidance to team members on compliance best practices and protocols, as needed. Provide periodic reporting to leadership on compliance status, issues, and remediation progress. Other duties as assigned. What We Look For Advanced knowledge of applicable laws, regulations, requirements, best practices, and regulatory trends that impact Affirm's business. Advanced knowledge in domain. Subject matter expert in completing end-to-end compliance testing and/or assessment activities with limited oversight. May lead a specific testing area. Excellent organizational and relationship leadership skills. Must be detail oriented, thorough, and well organized. Proactive and innovative mindset with proven experience in leading initiatives and driving a culture of compliance within an organization. Advanced project management, critical thinking, and analytical skills. Ability to collaborate cross-functionally with, and communicate complex regulations to, business partners. Strong working knowledge of analytical tools, such as Snowflake, Excel, and visualization software (e.g. Looker, Tableau, etc.). Inquisitive and proactive in proposing creative and effective solutions. Ability to manage multiple priorities and work under pressure. Proven experience as a key contributing member of an impactful and fast-paced team. Ability to thrive in an ambiguous context. Decision Making: Provides recommendations regarding methods, techniques and evaluation criteria for obtaining results and is able to make well reasoned recommendations on decisions, and decisions where appropriate, to help drive business outcomes. Manages multiple complex projects/initiatives/cross functional work. Individual Contributor, but will be a Program/Process owner. Professional work experience in Compliance Risk, Audit, or Bank Regulatory. A minimum of 6 years of experience in a regulated industry is highly preferred. Base Pay Grade - L Equity Grade - 6 Employees new to Affirm typically come in at the start of the pay range. Affirm focuses on providing a simple and transparent pay structure which is based on a variety of factors, including location, experience and job-related skills. Base pay is part of a total compensation package that may include equity rewards, monthly stipends for health, wellness and tech spending, and benefits (including 100% subsidized medical coverage, dental and vision for you and your dependents.) USA base pay range (CA, WA, NY, NJ, CT) per year: $160,000 - $210,000 USA base pay range (all other U.S. states) per year: $142,000 - $192,000 Please note that visa sponsorship is not available for this position. #LI-Remote Affirm is proud to be a remote-first company! The majority of our roles are remote and you can work almost anywhere within the country of employment. Affirmers in proximal roles have the flexibility to work remotely, but will occasionally be required to work out of their assigned Affirm office. A limited number of roles remain office-based due to the nature of their job responsibilities. We're extremely proud to offer competitive benefits that are anchored to our core value of people come first. Some key highlights of our benefits package include: Health care coverage - Affirm covers all premiums for all levels of coverage for you and your dependents Flexible Spending Wallets - generous stipends for spending on Technology, Food, various Lifestyle needs, and family forming expenses Time off - competitive vacation and holiday schedules allowing you to take time off to rest and recharge ESPP - An employee stock purchase plan enabling you to buy shares of Affirm at a discount We believe It's On Us to provide an inclusive interview experience for all, including people with disabilities. We are happy to provide reasonable accommodations to candidates in need of individualized support during the hiring process. [For U.S. positions that could be performed in Los Angeles or San Francisco] Pursuant to the San Francisco Fair Chance Ordinance and Los Angeles Fair Chance Initiative for Hiring Ordinance, Affirm will consider for employment qualified applicants with arrest and conviction records. By clicking "Submit Application," you acknowledge that you have read Affirm's Global Candidate Privacy Notice and hereby freely and unambiguously give informed consent to the collection, processing, use, and storage of your personal information as described therein.

Propelis, a renowned global brand services agency, is seeking a visionary Director of Governance, Risk, and Compliance (GRC) to drive transformation in its enterprise security posture. Situated in Chicago, IL, with a flexible remote work arrangement, this leadership role presents an exciting opportunity to shape and mature Propelis' governance, risk, and compliance programs on a global scale. Reporting directly to the SVP & Chief Information Security Officer (CISO), the Director of GRC will act as a strategic partner to executive leadership and business units worldwide. The successful candidate will lead a critical function, blending high-level strategy with hands-on execution, and will be central to ensuring Propelis fulfills its commitments to regulatory agencies, clients, and contractual stakeholders. This role also emphasizes building a risk-aware culture to empower the organization to operate and grow confidently in a rapidly evolving landscape. Key Responsibilities Governance Develop, implement, and maintain the Propelis GRC framework, aligning all relevant policies and standards to leading global benchmarks, including ISO 27001:2022, NIST 800-53r5, and HITRUST CSF. Facilitate governance committees and engage with executive leadership to promote effective risk oversight and accountability throughout the organization. Ensure GRC policies and standards are kept current, reviewed regularly, and consistently communicated across Propelis' worldwide operations. Risk Management Design and lead robust Technology Risk Management (TRM) and Participate in Enterprise risk management (ERM) and cybersecurity risk programs that support Propelis' strategic vision and business objectives. Maintain the corporate risk register, providing timely and actionable reporting on risk posture, emerging trends, and key risk indicators to senior leadership, including the CISO and CIO. Articulate and manage Propelis' risk appetite and tolerance, ensuring these parameters remain aligned with evolving business strategies and client expectations. Compliance Oversee organization-wide compliance initiatives, including ISO 27001 certification, SOC 2, GDPR, HIPAA/HITRUST, PCI DSS, and additional regulatory or contractual requirements as needed. Serve as the primary liaison to internal and external audit teams, leading efforts to ensure audit readiness, manage client assessments, and address findings proactively. Promote automation and continuous monitoring within compliance processes to minimize manual effort and enhance overall assurance and transparency. Third-Party Risk Lead the vendor risk management program, ensuring comprehensive supplier due diligence, ongoing monitoring, and rigorous contractual compliance. Partner with Procurement and Legal teams to embed security and compliance requirements into all phases of vendor engagement and relationship management. Leadership & Collaboration Build, mentor, and empower the GRC function, fostering a culture of accountability, professional growth, and continuous improvement within the team and across Propelis. Serve as a trusted advisor to the CISO and executive leadership, offering expert counsel on governance, risk, and compliance matters to inform decision-making at the highest levels. Collaborate closely with IT, Legal, Finance, Operations, and business units worldwide to seamlessly integrate risk and compliance considerations into daily operations and strategic initiatives. Qualifications Bachelor's degree in Information Security, Risk Management, Business, or a closely related discipline required. Minimum of 7 to 10 years of progressive experience in governance, risk, compliance, or information security, including at least 5 years in a leadership or management role. Deep knowledge of international frameworks and regulatory standards, including but not limited to ISO 27001/27005, NIST 800-53, HITRUST CSF, SOC 2, PCI DSS, HIPAA, and GDPR. Proven record of success in implementing enterprise risk management programs and compliance initiatives within complex, global organizations. Exceptional communication skills, with the ability to influence executive stakeholders and convey technical risk concepts in precise, business-oriented language. Preferred certifications include: CISM (Certified Information Security Manager) CRISC (Certified in Risk and Information Systems Control) CISA (Certified Information Systems Auditor) CISSP (Certified Information Systems Security Professional) ISO 27001 Lead Implementer/Auditor Personal Attributes Strategic thinker with a demonstrated ability to balance risk reduction and business enablement, ensuring security and compliance support-rather than hinder-organizational growth. Strong leadership presence, capable of driving accountability, setting direction, and inspiring teams across multiple geographies and domains. Collaborative and pragmatic approach to governance, compliance, and risk management, fostering relationships and encouraging shared ownership of enterprise security goals. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. This is a remote position in the US. We are open to candidates in various states, with the exception of those residing in the following: AK, DC, ME, NH, NM, OK, HI, MS, MT, NV, NE, ND, SD, VT, WY, WV Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The U.S. pay range for this position is $99,927 - $165,000 USD. Ultimately, in determining pay, we will consider the successful candidate's location, experience, and other job-related factors. Group benefits currently include a selection of health care plans with prescription drug coverage, dental plan, vision plan, basic and supplemental life insurance, a flexible spending account for medical and dependent care expenses or a health savings account based on plan selection, short/long term disability and 401(k) Savings Plan. #LI-SM1

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for Vistagen's products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle. This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Vice President, Global Regulatory Affairs. Key Duties & Responsibilities: Key responsibilities of this role include, but are not limited to: * Contribute to the regulatory strategy, development, and execution for Vistagen's products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes. * Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals. * Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies. * Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policies. * Oversee the preparation, review, and submission of regulatory submissions to health authorities. * Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects. * Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle. * Act as a primary regulatory point of contact for IND(s) with the U.S. FDA. * Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management. * Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practices. Qualifications: * Bachelor's degree in Life Sciences, Pharmacy, or related field. Advanced degree (Master's, PhD, or PharmD) is preferred. * 8-10 years of experience in Regulatory Affairs. * Proven track record of successful regulatory submissions and approvals in relevant markets. * Management and mentoring experience preferred. * In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH). * Experience with electronic submission systems (e.g. eCTD, SPL). * Regulatory writing and liaison experience is required. * Excellent written and verbal communication skills, with the ability to present complex information clearly. * Strong problem-solving abilities and attention to detail. * Strong project management and organizational skills. * Ability to work under pressure and manage competing priorities. Compensation and Benefits What we offer: * Industry competitive compensation * Performance-based bonuses * Stock options * Employee Stock Purchase Plan * 401k plan * A collaborative and innovative work environment at the forefront of biotech advancements Give your best, live wholesomely: * Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents * FSA and HAS * Basic Life Insurance 2x Earnings and AD&D * Employee Assistance Program * Healthcare advocates group to help navigate the healthcare system Work-life balance: * Unlimited paid time off * Flexible work schedule * Remote work option * Paid holidays * Mental health days * Winter shutdown * Casual work environment We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence. The anticipated salary range for candidates who will work remotely is $185,000-$215,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc. Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. Physical Demands: The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often. Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. This position requires the ability to lift and/or move up to 25 pounds occasionally. Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment. DISCLAIMER Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents. The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification. All Employee's have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) OVERVIEW OF THE COMPANY Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at *****************

Our healthcare system is the leading cause of personal bankruptcy in the U.S. Every year, over 50 million Americans suffer adverse financial consequences as a result of seeking care, from lower credit scores to garnished wages. The challenge is only getting worse, as high deductible health plans are the fastest growing plan design in the U.S. Cedar's mission is to leverage data science, smart product design and personalization to make healthcare more affordable and accessible. Today, healthcare providers still engage with its consumers in a “one-size-fits-all” approach; and Cedar is excited to leverage consumer best practices to deliver a superior experience. The Role U.S. healthcare is frustrating and deeply flawed. Cedar's mission is to drive better outcomes for everyone involved, including providers, insurance companies and the people they serve. At a time when consumer-friendly healthcare experiences are more critical than ever, our platform is uniquely equipped to solve problems that lead to billing issues and administrative waste. At Cedar, know that your work will have a meaningful impact on people's lives. Cedar is seeking an experienced Compliance Manager to be responsible for running and continuously improving key elements of Cedar's compliance program. Reporting directly to the Director of Compliance, this position will be a key individual contributor in the maturation and management of the compliance function at Cedar. Responsibilities Applying and interpreting audit and compliance requirements on behalf of the organization Coordinating the preparation and ongoing review of policies, procedures, training materials and other communication tools to ensure the organization meets compliance requirements Support the continued build out and operation of the Company's third party risk management program (TPRM), including policies and processes for conducting vendor due diligence and risk assessments, design and testing of controls, monitoring third-party activities, and providing ongoing training and reporting to stakeholders. Act as a liaison for Cedar's Compliance Program with both internal and external stakeholders. Coordinating assigned elements of external audits (including HITRUST, SOC2 Type II, PCI, and more) and interacting with external auditors Creating and reviewing compliance documentation Reviewing and assessing specific potential compliance issues and interacting with internal and external stakeholders to resolve them Contributing to risk-based compliance testing of controls to identify, correct, and detect noncompliance Coordinating rollout and training of new or updated policies and directives when required Support cross-functional teams to integrate compliance considerations into product development, operations, and business strategies. Support compliance training and awareness initiatives for employees to promote understanding of regulatory requirements and ethical standards. What we look for in an ideal candidate: At least four years of compliance experience An enthusiasm for building a great compliance function in a company that's still growing and scaling Experience implementing, using and optimising GRC tooling; experience with Vanta a plus A solid background in statistical, analytical, strategic and effective communication, writing, project management, and organizational skills. Proficiency in completing information security and compliance questionnaires. Working knowledge of the following frameworks(preferrably with some audit experience): HIPAA, HITRUST, SOC2, PCI and NIST; plus familiarity with laws, regulations, standards and guidelines applicable to healthcare businesses, including privacy and data security, medical billing and anti-kickback statutes. You may not know all of these deeply but should have solid familiarity and a willingness and excitement to learn what you don't already know. The ability to collaborate and build partnerships with colleagues throughout the organization. We're a small and mighty team where Compliance and Legal functions operate in a combined department and we're often closely paired with teams such as Security, IT, Product, Finance and Servicing. Compensation Range and Benefits Salary Range*: $148,750 - $175,000 This role is equity eligible This role offers a competitive benefits and wellness package *Subject to location, experience, and education #LI-REMOTE What do we offer to the ideal candidate? A chance to improve the U.S. healthcare system at a high-growth company! Our leading healthcare financial platform is scaling rapidly, helping millions of patients per year Unless stated otherwise, most roles have flexibility to work from home or in the office, depending on what works best for you For exempt employees: Unlimited PTO for vacation, sick and mental health days-we encourage everyone to take at least 20 days of vacation per year to ensure dedicated time to spend with loved ones, explore, rest and recharge 16 weeks paid parental leave with health benefits for all parents, plus flexible re-entry schedules for returning to work Diversity initiatives that encourage Cedarians to bring their whole selves to work, including three employee resource groups: be@cedar (for BIPOC-identifying Cedarians and their allies), Pridecones (for LGBTQIA+ Cedarians and their allies) and Cedar Women+ (for female-identifying Cedarians) Competitive pay, equity (for qualifying roles), and health benefits, including fertility & adoption assistance, that start on the first of the month following your start date (or on your start date if your start date coincides with the first of the month) Cedar matches 100% of your 401(k) contributions, up to 3% of your annual compensation Access to hands-on mentorship, employee and management coaching, and a team discretionary budget for learning and development resources to help you grow both professionally and personally About us Cedar was co-founded by Florian Otto and Arel Lidow in 2016 after a negative medical billing experience inspired them to help improve our healthcare system. With a commitment to solving billing and patient experience issues, Cedar has become a leading healthcare technology company fueled by remarkable growth. "Over the past several years, we've raised more than $350 million in funding & have the active support of Thrive and Andreessen Horowitz (a16z). As of November 2024, Cedar is engaging with 26 million patients annually and is on target to process $3.5 billion in patient payments annually. Cedar partners with more than 55 leading healthcare providers and payers including Highmark Inc., Allegheny Health Network, Novant Health, Allina Health and Providence.

This is a fully remote role. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. This role will be within our FSP group. We have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping and executing the global clinical regulatory strategy across client's development portfolio. This role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations, Clinical Development, Safety, and CMC leadership and serves as a key point of contact for global regulatory agencies on clinical matters. Key Responsibilities Strategic Leadership & Regulatory Planning Define and lead the company's global clinical regulatory strategy, ensuring alignment across programs, territories, and development milestones. Serve as the senior regulatory advisor to program teams, helping shape clinical development plans, scientific strategies, and geographic expansion. Stay abreast of the regulatory landscape and regulatory requirements. Anticipate regulatory challenges, conduct strategic risk assessments, and propose clear, data-driven mitigation strategies. Represent Regulatory Affairs leadership in governance forums, providing decision-making support and regulatory insights to senior management. Global Submission Strategy & Execution Oversee the planning, authorship, review, and delivery of all major clinical regulatory submissions, including: New Drug Application (NDA) IND/CTA filings and amendments Health authority pre-submission and post-submission packages DSURs, Annual Reports, SUSAR submissions Protocols, IBs, and related clinical documentation Lead cross-functional submission teams with CROs, ensuring clarity of roles, timelines, and quality expectations. Establish and continuously optimize submission processes, tools, templates, and governance standards. Core Dossier Management & Country Customization Direct the development, release, and lifecycle management of global core clinical dossiers, ensuring scientific rigor, regulatory compliance, and internal alignment. Drive strategies for efficient global rollout, including harmonization across regions and scalable dossier architecture. Provide executive-level guidance to regional teams on country-specific customization, ensuring adherence to local regulations, formats, language requirements, and health authority expectations. Approve localized submissions for strategic consistency and regulatory integrity. Regulatory RFIs & Agency Interactions Oversee the development of robust, scientifically sound, and timely Requests for Information (RFI) responses, ensuring alignment with overall regulatory and clinical strategy. Lead preparation for and participation in key regulatory interactions (FDA, EMA, MHRA, PMDA, and other agencies). Clinical Operations Partnership & Trial Execution Partner with Clinical Operations leadership to ensure regulatory considerations are fully integrated into trial startup, conduct, and closeout. Guide regional feasibility and startup planning from a regulatory perspective, including country prioritization and risk management. Oversee vendor and CRO performance related to regulatory responsibilities. Ensure organization-wide inspection readiness and provide senior oversight during audits and regulatory inspections. Knowledge, Skills, Abilities Education and Experience: Bachelor's degree in life sciences or related field; advanced degree strongly preferred 12+ years of regulatory affairs experience in biotech/pharma, including 5 years of substantial leadership experience supporting global clinical programs. Demonstrated success leading global IND/CTA submissions, dossier management, and regulatory interactions. Expertise in crafting high-quality RFI responses and managing complex regulatory communications. Deep knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.). Proven experience influencing cross-functional leaders and driving alignment on regulatory strategy. Outstanding communication, leadership, and organizational skills. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Preferred Experience with biologics, gene therapies, cell therapies, or other advanced modalities. Prior responsibility for global rollout of core clinical dossiers or large-scale clinical submission programs. RAC certification or equivalent credential. Experience in fast-paced or emerging biotech environments. Physical Requirements / Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations, frequent travels both domestic and international. Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Moderate mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

BrainChild Bio is seeking a Director, Regulatory Affairs, to lead and execute the regulatory strategy for our CAR T programs. This role will serve as BrainChild Bio's primary regulatory representative, responsible for guiding regulatory activities across preclinical, clinical, and manufacturing stages, while partnering closely with internal teams and external partners.The Director will work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. Responsibilities include developing regulatory strategies that support innovative CAR T development, preparing for and participating in FDA and ex-US health authority interactions, and ensuring documentation and filings are complete, accurate, and timely. The ideal candidate brings substantial experience in Regulatory Affairs within a clinical-stage biotech, strong working knowledge of FDA regulations for cell and gene therapy products, and the ability to operate both strategically and hands-on. We're seeking a collaborative, detail-oriented leader who thrives in a fast-moving environment and is motivated by bringing transformative therapies to patients.Responsibilities: Lead and execute regulatory strategies to support development of CAR T programs. Prepare, review, and submit INDs, amendments, and regulatory correspondence to FDA and other global health authorities. Serve as primary regulatory contact with health authorities, including FDA, EMA and other global agencies, representing BrainChild Bio in meetings and discussions. Collaborate cross-functionally with Clinical, CMC, Quality, and Patient Operations to ensure regulatory compliance and alignment with program objectives Identify risks and opportunities, providing strategic recommendations to accelerate development timelines. Advise on regulatory implications of protocols, manufacturing processes, and patient logistics. Manage regulatory timelines, submissions, and deliverables across multiple programs. Stay informed of emerging regulations, guidance documents, and industry trends specific to cell and gene therapy. Qualifications: 10+ years of regulatory affairs experience, including significant experience in cell and gene therapy, or advanced biologics. Strong working knowledge of FDA regulations and guidance for CAR T and other cell therapy products, as well as global regulatory frameworks. Demonstrated ability to develop strategic regulatory plans and execute them in a fast-paced clinical-stage biotech environment. Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution. Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders. Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies.

MedCerts - a Stride Inc. company (NYSE: LRN) - is a national online training provider strengthening the workforce through innovative eLearning solutions. Focused on certifications in high-demand areas of allied healthcare and IT, it serves individuals from all backgrounds, including the military and their families, career changers and the under- and unemployed. MedCerts delivers career training through HD-quality video-based instruction, virtual simulations, games and animations, and on-the-job training through Experiential Learning solutions. Since 2009, the company has developed over 45 career programs, trained and up-skilled more than 35,000 individuals across the country and partnered with over 500 American Job Centers and more than 1,000 healthcare and academic organizations to build talent pipelines, and provide the option of articulated college credit to our students. In 2020, MedCerts was acquired by Stride, Inc. Stride has transformed the teaching and learning experience for millions of people by providing innovative, high-quality, tech-enabled education solutions, curriculum, and programs directly to students, schools, the military, and enterprises in primary, secondary, and post-secondary settings. For more information, visit medcerts.com. The Regulatory Affairs and Compliance Director will lead the pursuit, organization, maintenance, and archival activities related to State Authorizations and Eligible Training Provider List Authorizations. Primary responsibilities include but are not limited to the submission of new and renewal applications, processing documents as required by funder organizations, monitoring outcomes for compliance, project evaluation, analyzing data and submitting reports. GENERAL DUTIES AND RESPONSIBILITIES Review and complete Master Agreements, contract, and applications for State Higher Education Boards, Workforce Investment Boards, and other regulatory entities. Completing ETPL applications for new state and regional sales territories Proactively inform leadership and sales leaders on all aspects of regulatory affairs for current statuses and future road mapping. Review and provide interpretation of proposal requirement Gather information regarding education laws, ordinances, and regulation Adding new program offerings or modifying program offerings on already approved state and regional ETPL approvals Assist all stakeholders with compliance reporting deadlines, licensing, authorization, and accreditation applications as needed Conduct research on various government agencies and identify new funding opportunities Other duties and special projects as assigned REQUIRED QUALIFICATIONS Direct, robust, and successful experience in regulatory affairs/compliance environments Bachelor's Degree is required, Master's degree is preferred Excellent oral and written communication Must have experience leading a team Work effectively in a fast-paced changing environment Ability to work under pressure and meet deadlines, while maintaining a positive attitude Ability to work independently and to carry out assignments to completion with limited guidance WORKING CONDITIONS This is a remote position in which work will be completed during normal business hours (approximately 8:30am - 5:00pm). COMPENSATION & BENEFITS: Stride, Inc. considers a person's education, experience, and qualifications, as well as the position's work location, expected quality and quantity of work, required travel (if any), external market and internal value when determining a new employee's salary level. Salaries will differ based on these factors, the position's level and expected contribution, and the employee's benefits elections. Offers will typically be in the bottom half of the range. We anticipate the salary range to be $68,598.80 - $138,674.53. Eligible employees may receive a bonus. This salary is not guaranteed, as an individual's compensation can vary based on several factors. These factors include, but are not limited to, geographic location, experience, training, education, and local market conditions. Stride offers a robust benefits package for eligible employees that can include health benefits, retirement contributions, and paid time off. Job Type Regular The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you can request the appropriate accommodation by contacting *********************. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Stride, Inc. is an equal opportunity employer. Applicants receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or any other basis prohibited by federal, state, or local law. Stride, Inc. complies with all legally required affirmative action obligations. Applicants will not be discriminated against because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

About the Company Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals. Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel. Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization. Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events. Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk. Responsible for company's product quality and reliability to meet or exceed regulatory. Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards. Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities. Support the quality system, provide effective leadership support, training, and guidance to all company personnel. Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner. Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures. Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions. Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management. Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible. Champion initiatives that contribute to global process improvements, which have a significant impact on business. Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors. Other projects or responsibilities as may be required. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the job. Minimum Qualifications - Education and Experience A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and international regulatory agencies is required for this position. Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 5-8 years of leadership experience in a global regulatory affairs role. Must have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP GMP, CLP guidelines and relevant requirements Substantial experience in all aspects of regulatory affairs, including Clinical, Commercial support, CMC, with a track record of successful submissions and license approvals with CDER and CBER Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions. Excellent working knowledge of the US, European and Asian regulations for drugs and biologics. Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. Must be able to travel (US/international) up to 25%. Preferred Qualifications - Education and Experience RAC Certification preferred Equal Opportunity Employer Adagene is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. Adagene will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. Adagene will consider for employment all qualified applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. Adagene participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. Adagene is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Adagene is a drug-free workplace.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO's and consultants. Desired Skills and Qualifications · Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

At JMAC Lending, we've been proudly serving our clients for over 25 years. What sets us apart is our commitment to innovation, exceptional service, and helping our partners grow their business. We go above and beyond the current market options to become the preferred lender for our clients. Our associates are highly qualified and continuously update their knowledge through ongoing education. We pride ourselves on our strong ethical standards and efficient delivery of wholesale and correspondent lending products. JMAC Lending is seeking an experienced and detail-oriented Compliance Manager to lead the company's compliance efforts and ensure adherence to all federal, state, and investor regulatory requirements. This role will be responsible for managing the compliance management system, providing expert guidance to staff and leadership, and driving process improvements that minimize risk while supporting business objectives. You'll oversee company-wide compliance initiatives, manage counterparty risk, licensing, vendor relationships, and play a critical role in maintaining JMAC's reputation for operational excellence and regulatory integrity. This is a Full-Time/Remote Opportunity offering competitive pay ranging from $80k - $120k plus bonus. Key Responsibilities:Regulatory Compliance & Oversight Stay current on federal, state, and investor regulatory requirements and upcoming changes impacting the mortgage industry. Interpret, analyze, and implement new regulations in collaboration with leadership. Develop, maintain, and review compliance-related policies, procedures, and controls to ensure ongoing adherence to applicable laws and guidelines. Advise management on risk mitigation strategies and enhancements to systems and processes. Training, Communication & Policy Management Design, implement, and deliver compliance-related training across the organization. Communicate regulatory changes effectively to staff and ensure timely adoption of updated policies and practices. Partner with external counsel to review and refine JMAC's policies and procedures. Counterparty & Licensing Management Oversee broker and correspondent compliance, ensuring adherence to investor and agency requirements. Manage company licensing, including state license approvals, renewals, audits, and regulatory reporting. Support the vendor management system and ensure proper due diligence on third-party providers. Operational Compliance & Risk Management Oversee JMAC's Anti-Money Laundering (AML) program, HMDA filings, and MERS audits. Respond to regulatory inquiries and manage external compliance audits. Monitor and enforce representations and warranties obligations with investors and agencies. Review and respond to consumer complaints, loan-level compliance issues, and inquiries from operations and sales teams. Requirements 5-10 years of experience in mortgage compliance management, preferably within wholesale or correspondent lending. Deep understanding of federal and state lending regulations, including RESPA, TILA, ECOA, HMDA, TRID, and AML. Strong knowledge of agency and investor guidelines. Excellent verbal and written communication skills with the ability to engage all levels of employees and leadership. Proven ability to manage multiple priorities in a fast-paced environment while maintaining exceptional attention to detail. Experience leading compliance audits and interacting with state regulators and investors. Hands-on experience with compliance management systems and licensing platforms. Strong analytical and problem-solving skills with a proactive approach to risk management Benefits Comprehensive Health Care Coverage including Medical, Dental, and Vision benefits Life Insurance options for both Basic coverage and Voluntary coverage, with Accidental Death & Dismemberment (AD&D) Generous Paid Time Off, including Vacation days and Holidays Secure Retirement Plan with a 401k option Support in case of Short Term or Long Term Disability Family Leave to prioritize your loved ones Access to Wellness Resources for a healthy work-life balance JMAC Lending, Inc. is an Equal Employment Employer. We are committed to workforce diversity. Qualified applicants will receive consideration without regards to age, race, religion, sex, sexual orientation, gender identity or national origin. DISCLAIMER: JMAC Lending is an evolving company. As such this job description is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Director Cold Chain Management & GDP Compliance Fully remote role, US Candidates SUMMARY DESCRIPTION The Director, Cold Chain Management & Supply Chain GDP is a key role as part of the Global Distribution organization. This role is critical to ensuring the integrity of temperature-sensitive pharmaceutical products throughout the supply chain, while maintaining full compliance with Good Distribution Practice (GDP) regulations and internal quality standards. The incumbent will lead the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of all clinical and commercial materials in BioMarin. RESPONSIBILITIES Cold Chain Engineering * Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products. * Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities. * Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets. * Drive innovation in cold chain technologies and the streamlined management and quality of associated data. Supply Chain Compliance & GDP * Ensure global compliance with GDP regulations and internal quality standards across all distribution channels. * Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity. * Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations. * Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps. Leadership & Strategy * Direct management of a team of individual contributors across global regions * Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities. * Advise senior leadership on investment decisions and emerging trends, providing timely risk insights and strategic recommendations that support informed decision-making. SCOPE This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes: * A firm commitment to BioMarin's cultural beliefs and values * Consistent track record of exceeding objectives within area of influence * Ability to achieve results through others without direct reporting lines * Strong problem-solving skills with a global focus both internally and externally * Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry * Flexibility and ability to deal with changing priorities without losing sight of the overall business * Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change * Proactive and energetic outlook with an unwillingness to accept the status quo * Interaction and collaboration with team members, peers and senior management * Ability to work independently with strong time management skills EDUCATION * Bachelor's or Master's degree in Engineering, Supply Chain, Life Sciences, or related field. * 10+ years of experience in pharmaceutical supply chain, with significant expertise in cold chain and GDP compliance. * Proven leadership experience in a global, matrixed organization. * Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.). * Excellent communication, stakeholder management, and problem-solving skills. Preferred Qualifications: * Experience with biologics, vaccines, or advanced therapies. * Familiarity with digital monitoring systems and data analytics in cold chain. * Lean Six Sigma or similar process improvement certification. EXPERIENCE * Bachelor's degree in related curriculum with a minimum of 10-12 years of experience in global trade compliance * Previous experience leading a global team * Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes). * Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions to make the company's Trade Compliance stronger and more efficient. * Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk * Ability to effectively work autonomously and independently Circa 15% travel CONTACTS Commercial, Site Operations, Clinical Supply Chain Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance External partners including 3PL providers, transport carriers. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The salary range for this position is: $169,300 to $253,900. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

YOUR PASSION, ACTIONS & FOCUS is our Strength. Become one of our Contributors! Join the KnipperHEALTH Team! The Pharmacy Compliance Manager plays a key role in maintaining the integrity, accountability, and compliance posture of the organization. This position serves as the primary lead for Accreditation, Board of Pharmacy, and client audit readiness, The Compliance Manager is responsible for ensuring that all compliance issues, investigations, and corrective actions are documented, tracked, and closed effectively, and that CPS remains fully compliant with HIPAA, NABP, ACHC, DEA, and applicable state and federal pharmacy regulations. This position reports to the Vice President, Pharmacy Compliance and partners closely with Operations, Quality, and Legal teams. Exciting remote opportunity! Sponsorship is not being offered for this role. Responsibilities Compliance Program Support Support the execution of the Pharmacy Compliance Program, including education, monitoring, and reporting activities. Prepare and present quarterly compliance metrics, CAPA summaries, and privacy updates to the Compliance Committee. Assist with policy development, updates, and integration into the Knipper Health corporate compliance framework. Assist with development and execution of internal auditing procedures. Contribute to audit readiness by maintaining organized, current evidence files for compliance and privacy controls. Participate in internal and client audits; provide documentation and corrective follow-up. Coordinate compliance training for employees and contractors related to HIPAA, CAPA, and corporate conduct. Accreditation, Regulatory, Client Compliance Management Serve as the Accreditation Lead for ACHC, NABP, and other certification and regulatory bodies relevant to pharmacy operations. Maintain current knowledge of all accreditation standards and regulatory updates impacting pharmacy operations. Lead all reaccreditation and audit readiness activities, including documentation review, evidence collection, and staff preparation. Maintain a master library of accreditation policies, procedures, and evidence documents. Collaborate with Quality and Operations to close accreditation-related CAPAs or deficiencies. Ensure ongoing compliance with all accreditation standards through continuous monitoring, periodic internal audits, and staff education. Act as the primary liaison to accrediting bodies, external auditors, and regulatory agencies. Coordinate accreditation committee meetings and maintain minutes and corrective action logs. The above duties are meant to be representative of the position and not all-inclusive. Qualifications MINIMUM REQUIREMENTS: Pharm D or Bachelor of Science Degree in pharmacy Ten (10) years of Pharmacist experience Current unrestricted license to practice pharmacy in good standing by the required state(s) board(s) of pharmacy. Ability to acquire other licenses as needed. Minimum 5 years of experience in compliance, quality assurance, or regulatory affairs within a specialty or mail-order pharmacy environment. Demonstrated experience leading accreditation/compliance programs. Working knowledge of HIPAA Privacy & Security, NABP, ACHC, DEA, and 21 CFR Part 11. Strong analytical and documentation skills with attention to detail and deadlines. Proficient with compliance or QMS platforms (e.g., Track-wise, Master-Control, ZenQMS, or equivalent). Ability to communicate effectively across clinical, operational, and executive teams. Prior experience presenting to compliance committees or regulatory inspectors preferred. Proficient in the area of clinical interpretation; drug-drug, drug-disease, drug-food interaction and allergies HIPAA, Fraud Waste and Abuse and Confidentiality training Demonstrated knowledge of regimens, products, medication, and supplies Demonstrated experience providing exceptional customer service PREFERRED EDUCATION AND EXPERIENCE: Previous experience in applicable pharmacy practice area Understanding or knowledge of medication claims processing systems and/or medical information systems Unrestricted multiple state pharmacist licenses, a plus. KNOWLEDGE, SKILLS & ABILITIES: Integrity & Accountability: Models ethical conduct and reinforces compliance culture. Critical Thinking: Skilled in analyzing root causes, patterns, and systemic risks. Leadership & Collaboration: Partners cross-functionally to drive sustainable improvements. Technical Proficiency: Demonstrated understanding of pharmacy operations, data protection, and regulatory standards. Communication: Clear, concise, and confident in reporting findings and recommendations. Excellent written and verbal communication skills Excellent analytical, problem solving and decision-making skills Computer skills including Microsoft Office products Ability to accept changing work-flows and unexpected demands Ability to work under pressure and appropriately prioritize responsibilities Ability to work independently with minimal supervision Ability to work in a team-oriented environment and develop collaborative working relationships Ability to enter data and retrieve patient information Ability to present information clearly and professionally to varying levels of individuals throughout the patient care process PHYSICAL DEMANDS: Location of job activities 100% inside Noise and/or vibrations exposure Reaching (overhead), handling, and feeling Stand and sit for prolonged periods of time Extensive manual dexterity (keyboarding, mouse, phone) Use of phone for communication Ability to travel out of state 25% Lift, carry, and move up to 20 pounds Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Knipper Health is an equal opportunity employer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. Responsibilities and Accountabilities: Strategic Leadership: Define and implement global CMC regulatory strategies with a strong focus on North American requirements. Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. Policy & Advocacy: Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. Cross-Functional Collaboration: Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. External Engagement: Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. Lead advocacy initiatives for innovative technologies and precedent-setting projects. Operational Excellence: Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). Ensure consistency and quality in dossier preparation across regions. Expected Key Accountabilities from Global Regulatory Aspects Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility.

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. Position Summary: The Manager, Scientific Affairs will be a key player in the Scientific Affairs team as part of the greater Medical Affairs department. They will serve to support integration of scientific discovery and implementation of new product development. This individual will be responsible for evaluating ingredient supplier clinical studies to ensure the scientific rigor and standard required for Thorne innovation. This individual will possess a high level of knowledge in dietary supplement ingredients, sourcing, and utilization. As part of the Scientific Affairs team, they will ensure the transition of scientific and medical claims discovery to the Medical Affairs team for substantiation. This individual will support the collaboration between the greater Research and Development functions of the company and the commercialization teams within Medical Affairs, Sales, and Marketing. Successful candidates for this role will have deep expertise in vetting scientific literature for validity, accuracy, regulatory qualification, and value to company product strategies. This is a remote position. Responsibilities * Integral to the day-to-day activities of the Scientific Affairs team, including ingredient research, literature reviews and dossier development. * Provides support to the greater Scientific Affairs team by coordinating meetings, managing calendars, tracking new ingredient inquiries, supplier communications, and project status. * Assists in the organization and maintenance of Scientific and Medical Affairs templates, scorecards and additional in-house tools. * Prepares and organizes materials for internal presentations and supports ongoing data tracking needs * Independently functions as an integral member of the Scientific Affairs team in creating a pipeline of new ingredients for consideration in new product development and existing product reformulations. * Provides scientific expertise and input in communicating product use to internal stakeholders across departments. * Supports the creation of claims dossier outlines with an organized and efficient handoff to the Medical Affairs team to finalize claims substantiation. * Establishes and maintains an extensive contact and networking system of innovative ingredient suppliers who meet the Company's quality standards in collaboration with the greater R&D team. * Provides flexible support across Scientific and Medical Affairs projects as needed. * Supports the strategy for Thorne to be recognized as a leader in product science, quality and innovation. * Provides strategic oversight regarding industry trends and new developments with the goal of supporting new business and creating strategic plans that drive integration of the offerings of the company. * Participates in and supports new products, services, and business development initiatives that generate potential revenue creation and growth. * Ensures open and proactive communication between Research & Development, Medical Affairs, Sales, Marketing and other company representatives. What You Need * Bachelor's degree required in nutrition, chemistry, biology, or related field; Master's degree or equivalent research experience preferred. * Deep understanding and ability to critically assess scientific literature for accuracy, rigor, and clinical application. * Comprehensive understanding of emerging trends in the dietary supplement marketplace, and how they may relate to promotional and clinical practices. * Candidates with dietary supplement experience from high-quality, science-first companies will be prioritized. * Highly organized, proactive and capable of balancing both scientific detail and administrative execution * High level of nutritional product knowledge and appropriate use in new product development. * Demonstrates ability to develop and deliver upon business objectives. * Ability to build, develop, motivate and manage high-performance teams. * Comfort with and extensive experience interacting with others at all levels within and outside of the Company. What We Offer * Competitive compensation * 100% company-paid medical, dental, and vision insurance coverage for employees * Company-paid short- and long-term disability insurance * Company- paid life insurance * 401k plan with employer matching contributions up to 4% * Gym membership reimbursement * Monthly allowance of Thorne supplements * Paid time off, volunteer time off and holiday leave * Training, professional development, and career growth opportunities Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com. THORNE IS AN EQUAL OPPORTUNITY EMPLOYER #LI-SC1

Job Title: Ethics & Compliance Manager - Based in Alpharetta, GA or Remote Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: * Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; * Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; * Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Employment for customer facing roles is contingent upon your ability to satisfy all vendor credentialing requirements. If you are unable to be credentialed, Avanos reserves the right to withdraw your employment offer or end your employment. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit *************** Essential Duties and Responsibilities: The Manager, Ethics & Compliance provides leadership and support for all elements of the Ethics & Compliance Program including business team guidance, communication of compliance written standards, key control testing for significant risks, and other related activities as necessary. This role supports various Avanos teams and departments with guidance and recommendations to accomplish business objectives and strategic initiatives, and ensure compliance with applicable laws, regulations, and Avanos policies. Key Responsibilities: Oversight: Supports the implementation of the Global Compliance Program under the direction of the Chief Ethics & Compliance Officer. The responsibilities include supporting Management Compliance Oversight Committee and other Ethics & Compliance meetings, activities; enhancing and implementing processes as needed; and supporting efforts to advance Avanos Ethics & Compliance Culture. Advice and Guidance: Provides day-to-day advice and guidance to relevant business teams on Ethics & Compliance matters. Risk Assessment Activities: Supports the annual Risk Assessment and reviews activity-specific plans by the business teams. Provides training and guidance on the Risk Assessment process, including development of tools as required. Written Standards: Provides support on the drafting, implementation and communication of Compliance-related policies and procedures. Program Management: Implements actions as specified in the annual work plan and KPIs. Training and Communications: Supports the implementation of the annual training and education plans. Develops communications on key Ethics & Compliance risks and initiatives, as requested. Supplements with additional training as requested, according to the needs of the business. Monitoring and Auditing: Supports the Audit, Monitoring and Investigations teams in activities as required. Implements monitoring processes in applicable businesses, including ride-a-longs with field personnel. Third Party Management: Supports Third Party Seller and Non-seller Third Party (NSTP) compliance management and initiatives, including processes for Third Party Risk Assessments and site visits. Investigations: Conducts and/or assists in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports. Ensures consistent and appropriate investigative processes are utilized. Corrective Actions: Implements and tracks appropriate and consistent corrective actions for identified compliance issues and assessment activities. Conducts assessments to determine effectiveness of corrective actions. Your qualifications Required: * Bachelor's degree or its non-U.S. equivalent - required. * 4+ years of experience at a medical device, pharmaceutical, or other healthcare organization implementing a compliance program or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions). * Expertise in Marketing or other fields will be considered upon demonstration of skill sets needed to perform the job duties. * Experience in Healthcare industry - Device, Pharma, or Biotech is preferable. * English language fluency required. * Valued Advisor to business leaders with experience finding solutions to complex ethical issues. * Excellent research, writing, and communication skills, and excellent ability to analyze complex matters and present them simply and clearly. * Excellent organizational and time management skills with the ability to prioritize and manage a heavy and multi-directional workload. * Demonstrates Integrity and commitment to the highest ethical standards and personal values. * Ability to work independently and as part of a team (cooperative, encourages collaboration, builds consensus, easily gains the trust and support of superiors and peers, and finds common ground and solves problems). * Excellent research, writing, and communication skills, and demonstrated ability to analyze complex matters and present them simply and clearly. * Self-motivated and result driven. * Instinct to detect risk areas and red flags. * Solution-minded; desire to solve problems. * Ability to work in a matrixed organization, across cultures and functions with all levels of the organization. * Ability to prioritize according to risk and make quick decisions with appropriate independence. * Ability to deal with ambiguity and change. * Ability to follow through and complete tasks on time. * Ability to think strategically and also excel at tactical responsibilities. * Natural leadership ability with enthusiasm, confidence, and self-esteem, balanced with a caring for people that invites others to seek his or her advice and judgment and encourages teamwork and cooperation. * Strong business acumen with good judgment and can provide business partners with timely and appropriately risk-balanced advice and guidance. * Stamina and self-assurance to maintain effective working relationships in a demanding and diverse environment. * Contributes to an environment of respect and collaboration with peers and other stakeholders. * Exemplifies the values recognized as critical to Avanos: Customer-Centric, Global Mindset, Accountability, Collaborative, Candor, and Speed. Preferred: * Advanced degree, including MBA, JD, or equivalent - preferred. * Specific training in healthcare compliance, privacy and other related topics - preferred. * Fluency in other languages preferred. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. Salary Range: The anticipated average base pay range for this position is $104,000.00 - $121,000.00. In addition, this role is eligible for an attractive incentive compensation program and benefits. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please

Toast is driven by building the all-in-one restaurant platform that helps restaurants operate their business, increase sales, engage guests, and keep employees happy. The Toast Fintech Compliance Program provides a compliance by design embedded approach to compliance program management , with an emphasis on product lifecycle management, while enabling the business to innovate and deliver quality products and solutions to serve our customers. Toast, Inc. seeks a strategic, commercially oriented, forward thinking Director to lead the Compliance organization supporting the Fintech business. Reporting to the Chief Compliance Officer, the Director is responsible and accountable for establishing, managing, and maintaining quality compliance programs for Fintech products and directing the Fintech compliance team in the ongoing management of the product specific compliance management systems. Products in scope include: commercial lending program, leases, commercial deposit account, payment facilitation, debit cards, prepaid payroll cards, earned wage access, billpay and stored value cards. This role is also responsible for the maintenance of state money transmitter licenses and compliance with associated requirements. About this roll * (Responsibilities): Compliance leader managing compliance team supporting Fintech products. Oversee the development and maintenance of product-specific compliance management programs within Toast's Fintech Line of Business. Direct the Fintech Compliance team on establishing best-in-class compliance management systems, mitigation of key compliance risks related to in-scope products, and the remediation of process and control gaps. Products in scope include: commercial lending program, leases, commercial deposit account, payment facilitation, debit cards, prepaid payroll cards, earned wage access, billpay and stored value cards. Serve as a compliance thought partner to Fintech business stakeholders in the design and implementation of products/product enhancements. Guide Fintech Compliance team in product reviews to ensure regulatory compliance requirements are met. Serve as compliance sponsor on compliance committees. Escalate key compliance risks and issues to Chief Compliance Officer and governing bodies, such as the Enterprise Risk and Compliance Committee. Review results from compliance testing programs to identify themes or trends in findings and gaps. Mature and enhance Fintech compliance program and/or framework to address. Ensure product specific regulatory changes are monitored and assessed, and communicated to business partners in a timely manner. Oversee partner relationships and ensure obligations are met, including, but not limited to timely and accurate reporting and successful completion of partner reviews and required testing. Serve as an escalation point for concerns and issues raised by key partner contacts. Maintain state money transmitter licenses and compliance with associated requirements. Do you have the right ingredients* ? (Requirements): Bachelor's Degree required and CRCM preferred. Strong knowledge of financial laws and regulations, including: CFPB regulations (most specifically Reg B, Reg E, Reg P, and Reg Z); federal and state consumer protection laws (most specifically UDA(A) P, CAN SPAM, and TCPA); other laws and industry best practices related to commercial and consumer credit, prepaid debit cards, and electronic funds transactions; money transmitter laws, and card association and payment network rules. Direct experience leading compliance programs for financial products and services, specifically payment processing, money transmission, and banking products which may include: commercial and consumer credit, purchase financing, deposit accounts, debit, credit, and stored-value cards, bill pay services, and earned wage access. Typically requires 15+ years of related experience with a Bachelor's degree; or 12+ years and a related Master's degree. 10+ years of experience in a compliance, risk, or audit role at a financial institution providing commercial and/or consumer non-investment banking products (Fintech or payments industry preferred). Experience maintaining fintech-oriented frameworks, bank partnerships and third party vendors programs. Familiarity with operational processes and regulations related to banking products. Ability to work well with ambiguity and synthesize large amounts of complex information. Strong communication skills (both written and verbal). Special Sauce (Nice-to-Have Skills): CAMS AI at Toast At Toast we're Hungry to Build and Learn. We believe learning new AI tools empowers us to build for our customers faster, more independently, and with higher quality. We provide these tools across all disciplines, from Engineering and Product to Sales and Support, and are inspired by how our Toasters are already driving real value with them. The people who thrive here are those who embrace changes that let us build more for our customers; it's a core part of our culture. Our Spread* of Total Rewards We strive to provide competitive compensation and benefits programs that help to attract, retain, and motivate the best and brightest people in our industry. Our total rewards package goes beyond great earnings potential and provides the means to a healthy lifestyle with the flexibility to meet Toasters' changing needs. Learn more about our benefits at ******************************************** #LI-REMOTE The base salary range for this role is listed below. The starting salary will be determined based on skills and experience. In addition to base salary, our total rewards components include cash compensation (overtime, bonus/commissions, if eligible), benefits, and equity (if eligible). Pay Range$171,000-$274,000 USD Diversity, Equity, and Inclusion is Baked into our Recipe for Success At Toast, our employees are our secret ingredient-when they thrive, we thrive. The restaurant industry is one of the most diverse, and we embrace that diversity with authenticity, inclusivity, respect, and humility. By embedding these principles into our culture and design, we create equitable opportunities for all and raise the bar in delivering exceptional experiences. We Thrive Together We embrace a hybrid work model that fosters in-person collaboration while valuing individual needs. Our goal is to build a strong culture of connection as we work together to empower the restaurant community. To learn more about how we work globally and regionally, check out: ********************************************* Apply today! Toast is committed to creating an accessible and inclusive hiring process. As part of this commitment, we strive to provide reasonable accommodations for persons with disabilities to enable them to access the hiring process. If you need an accommodation to access the job application or interview process, please contact candidateaccommodations@toasttab.com. ------ For roles in the United States, It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

EQT is one of the United States' leading producers of natural gas and the first traditional energy company of scale in the world to achieve Net Zero on a Scope 1 and Scope 2 basis. From the office to the field, the #EQTeam is fueling the future. Power your potential with us. At EQT, we are making strides toward becoming the best producer by creating long-term value for all stakeholders, including employees, landowners, communities, industry partners and investors. Our vision is to evolve EQT into a modern, connected, digitally enabled organization. With an incredibly collaborative culture and a determined, progressive workplace, EQT was both named a National Top Workplace, as well as one of Pittsburgh's Best Places to Work! Join our Qrew! The Compliance Lead, Regulatory Compliance supports EQT's enterprise compliance framework by leading execution of key regulatory compliance activities throughout the organization. This role coordinates regulatory tracking, impact assessment, and change management efforts, ensuring that new or evolving requirements are efficiently assessed, communicated, and integrated into business operations. Working cross-functionally with Legal, Operations, Upstream, Midstream, Environmental, and Safety teams, this position helps drive consistency, strengthen controls, and reinforce a culture of proactive compliance across the organization. The Compliance Lead, Regulatory Compliance responsibilities include but are not limited to: Maintain EQT's regulatory repository and compliance control documentation to ensure requirements remain current, traceable, and actionable. Track and assess regulatory developments affecting upstream and midstream operations, as well as the domestic and international supply of natural gas to customers. Lead the regulatory impact assessment process, coordinating input from business stakeholders to evaluate applicability and operational impact. Partner with compliance champions and process owners to embed regulatory obligations into procedures, training, and monitoring activities. Support the development and execution of remediation and control improvement plans for identified compliance risks or findings. Analyze preventable notices of violation (NOVs) and similar enforcement actions to identify root causes and drive sustainable corrective actions. Coordinate compliance change management activities, ensuring updates to requirements are communicated, documented, and operationalized. Provide data-driven insights to inform compliance reporting, audits, and management reviews. Contribute to continuous improvement initiatives by identifying efficiency opportunities in compliance monitoring, documentation, and reporting. Required Experience and Skills: Bachelor's degree in law, engineering, environmental science, business, or a related discipline. 7-10 years of progressive regulatory compliance experience in the natural gas, midstream, or broader energy sector. Proven ability to interpret, implement, and operationalize requirements from agencies such as FERC, PHMSA, EPA, OSHA, and state-level regulators. Experience maintaining compliance repositories, impact assessments, or control frameworks. Strong analytical and problem-solving skills, with the ability to assess regulatory risk and drive remediation activities. Excellent communication and collaboration skills; able to influence and coordinate across diverse teams and functional areas. Demonstrated integrity, judgment, and discretion when managing sensitive or confidential information. Skilled in managing multiple priorities and adapting to a dynamic regulatory environment. Proficiency with GRC platforms, data analytics, or regulatory tracking systems preferred. Preferred Experience and Skills: Advanced degree (JD, MBA, or master's) or professional certification (CCEP, CRCM, CPCU, CAMS). Experience supporting or enhancing compliance management systems and regulatory reporting tools. Strong understanding of regulatory frameworks and enforcement practices relevant to the natural gas industry. Prior experience coordinating compliance change management or regulatory implementation projects. Effective at developing presentations and reports for business and regulatory audiences. Ability to mentor junior compliance staff or serve as a subject matter resource within the compliance program. Remote work is being considered for this role excluding the following states: California, Connecticut, Delaware, Illinois, Indiana, Louisiana, Massachusetts, Michigan, New Jersey, New York, and Tennessee unless willing to relocate. Selected incumbent will be placed into the position that best suits their abilities and experience level. EQT Corporation and its subsidiaries is an Equal Opportunity Employer -- Disabilities/Veterans.

Career CategoryRegulatoryJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity Live What you will do Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. To lead GRTs within Amgen's GRAAS organization To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions) Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood Lead GRTs and product teams in formal and informal communications with regulatory agencies Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy Represent Amgen Regulatory on external partnership teams at the product level Lead regulatory process improvements and initiatives Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 5 years of regulatory experience in biotech or science OR Master's degree and 8 years of regulatory experience in biotech or science OR Bachelor's degree and 10 years of regulatory experience in biotech or science Preferred Qualifications: Contemporary obesity experience desired Demonstrated ability to lead regulatory aspects of highly complex programs in late development Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application Ability to lead and build effective teams Strong communication skills - both oral and written Ability to understand and communicate scientific/clinical information Ability to anticipate and mitigate against future strategic issues and uncertainties Ability to resolve conflicts and develop a course of action Cultural awareness and sensitivity to achieve global results Planning and organizing abilities Able to prioritize and manage multiple activities Ability to make complex decisions and solve problems Ability to deal with ambiguity Organizational savvy Negotiation skills Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #Obesity . Salary Range 216,805.00 USD - 259,624.00 USD

The Operational Excellence & Compliance Manager, NMS Food Service, position is responsible for developing, implementing, and maintaining operational standards across NMS service lines to ensure excellence in quality, compliance, and customer satisfaction. This role oversees systems, processes, and training program implementation that support consistent performance and adherence to regulatory requirements and client expectations. This is a remote, work from home, position which requires travel. Travel schedule will be up to one week (7 days) at a time per location. The hired individual must live or be willing to relocate to Alaska. Responsibilities * Establish and maintain standards for food production, service quality, and operational compliance. * Develop and implement training programs to ensure team alignment with company standards. * Oversee menu and recipe development, ensuring nutritional, cultural, and cost considerations are met. * Manage contracted purchasing and inventory systems to optimize efficiency and cost control. * Ensure compliance with health, safety, and regulatory requirements across all operations. * Collaborate with leadership to drive continuous improvement initiatives and enhance customer experience. * Monitor and audit quality assurance programs, identifying gaps and implementing corrective actions. * Prepare and present reports. Data Analysis & Reporting * Analyze operational data and key performance indicators (KPIs) to identify trends, inefficiencies, and opportunities for improvement. * Prepare and present performance reports and insights to senior leadership to support data-driven decision-making. Technology Integration * Evaluate and implement digital tools and platforms that enhance operational efficiency, quality control, and compliance. * Lead system rollouts, ensuring effective training and user adoption across teams. Cross-Functional Collaboration * Facilitate cross-divisional and inter-agency collaboration to standardize practices and support knowledge transfer, ensuring continuity and efficiency. Continuity of Operations * Collaborate with managers to develop and maintain standard operating procedures (SOPs) and desk manuals. * Ensure new business start-up plans are developed, implemented, and regularly reviewed. * Lead succession planning initiatives to identify and develop internal talent for future key roles. Sustainability and Cultural Sensitivity * Promote sustainable practices in food service operations, including waste reduction and responsible sourcing. * Ensure cultural appropriateness in menu planning and service delivery, with a focus on meeting the needs of Alaska Native communities. Qualifications * High School Diploma or GED equivalent. * Minimum of five (5) years of progressive experience in food service operations, culinary management, or quality assurance within a multi-site or contract service environment. * Certified Dietary Manager (CDM). * Demonstrated experience in developing, implementing, and auditing SOPs related to food production, sanitation, and safety. * Proven track record in training program design, implementation, and evaluation for food service or hospitality teams. * Experience with menu standardization, production records, recipe management systems, and portion control standards. * Strong understanding of forecasting, food cost management, purchasing, inventory and labor management concepts. * ServSafe Manager Certification. * High level of acuity with the use of technology; Must be highly proficient in using the Microsoft Office Suite applications (Outlook, Teams, Word, Excel, PowerPoint, etc.) * Must pass a fingerprinting background investigation that complies with The Crime Control Act, Child Care Worker Act and the Indian Child Protection and Family Violence Prevention Act. * A valid Driver's License and an acceptable driving record for the past three (3) years to be eligible under NMS' vehicle insurance. This includes no DUI convictions in the past five (5) years. * Must be fluent in speaking, reading, and writing English. Preferred Requirements * Bachelor's degree in Hospitality Management, Culinary Arts, Food Science, Business Administration, or related field. * Working knowledge of healthcare regulatory compliance (Joint Commission/CMS). * Certified Executive Chef (CEC). Skills and Abilities * Strong analytical and problem-solving skills to identify trends and develop process improvements. * Excellent communication and presentation skills for leading training and quality reviews. * Proficiency in Microsoft Office Suite; familiarity with digital auditing or quality management systems preferred. * Ability to travel to various client sites or operational locations as needed (typically 20%). * Demonstrated leadership and influence across functional teams without direct authority. * Strong organizational and project management skills with attention to detail and follow-through. Working Conditions and Physical Requirements Weather: Indoors; employee is primarily in a controlled, temperate, environment. Noise level: Work environment is usually moderate to loud. Description of environment: Professional kitchen environment which will vary based on the location of the facility. Physical requirements: Employee is required to lift and/or move up to 50 lbs. Frequently to constantly required to sit, stand, walk, use hands/fingers to handle or feel, climb, stoop, kneel, crouch or crawl, talk/hear, see/taste/smell, and carry weight/lift. Travel: Extensive travel, up to 20% of the time. Competencies NMS Core Values Safety guides our behavior. Honesty and integrity govern our activities. Commitments made will be fulfilled. All individuals are treated with dignity and respect. The environment will be protected and sustained.