Ethics officer jobs near me - 146 jobs

EXCITED TO GROW YOUR CAREER? WE'RE GLAD YOU'RE HERE!Maritz is seeking a Compliance & Program Manager (HCP Events). This role combines healthcare compliance expertise in event management with planning & event management (planning approximately 15%). Acting as the primary client liaison, you'll ensure adherence to life sciences compliance regulations while overseeing HCP transfer of value reporting, financial accuracy, and operational coordination for assigned events. The position requires balancing regulatory standards with client objectives to deliver exceptional service and flawless execution. What You'll Be Doing 60% - Compliance Oversight & Reporting:Ensure all events comply with HCP (Healthcare Provider) regulations and client-specific compliance guidelines. Maintain and update SOPs, manage HCP documentation templates, and oversee the accuracy of websites and registration platforms (e.g., Cvent). Generate aggregate spend and quality control reports, resolve data issues, and ensure timely and accurate HCP payments and honoraria. 15% - Program Planning & Execution:Lead the end-to-end planning and execution of meetings and events. Manage timelines, budgets, and logistics including venue sourcing, AV, DMCs, air travel, and third-party contracts. Coordinate site inspections, facilitate client working sessions, and ensure internal teams are aligned with program goals. 10% - Financial Management:Oversee program financials including forecasting, tracking, and reconciliation. Manage supplier payments, client invoicing, and change orders. Audit final billing documentation to ensure accuracy and compliance with financial policies. Collaborate with accounting and clients to resolve outstanding items. 10% - Client & Team Communication:Act as the main point of contact for clients and internal stakeholders. Lead status meetings, maintain project documentation, and provide clear direction to project teams. Ensure alignment with client expectations and service level agreements (SLAs). 5% - Special Projects & System Management: Support special projects as assigned. Maintain data integrity within client systems (e.g., Cvent), including contract information, SLAs, and custom fields. Ensure timely and accurate data entry by event managers. What You'll Bring 5+ years of experience in event management, preferably in the life sciences or healthcare sector. Strong knowledge of HCP compliance regulations and aggregate spend reporting Proficiency in event management platforms (e.g., Cvent) Excellent organizational, communication, and financial management skills Ability to manage multiple priorities in a fast-paced environment Things You Should Know This is remote position. Some travel may be required. DISCLAIMER: This job description is designed to indicate the general nature and level of work performed by associates within this classification. It is not designed to confirm or be interpreted as a comprehensive summary of all duties, responsibilities and qualifications required of associates assigned to this job. Maritz offers a comprehensive benefits package for full-time employees including medical, dental, vision, life insurance, disability, 401k, tuition reimbursement, paid time off, and more! Part-time employees may qualify for medical, 401k, and paid time off depending on total hours worked. View all details at *********************** Maritz will only employ applicants who have authorization to work permanently in the U.S. This is not a position for which sponsorship will be provided. Those who need sponsorship for work authorization now or in the future are not eligible for hire. No calls or agencies please. Maritz is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment. If you have a disability and are having difficulty accessing or using this website to apply for a position, you can request help by calling or by sending an email to .

A financial services company based in Palo Alto is looking for an experienced Associate General Counsel to support regulatory compliance and government relations. The successful candidate will have a J.D., be eligible for in-house practice, and possess 4-7 years of relevant experience. Responsibilities include managing regulatory frameworks, collaborating with legislative representatives, and advocating for consumer finance standards. This role is remote-first, allowing flexibility while contributing to a mission-driven culture. #J-18808-Ljbffr

Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine. Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference. Our Mission We're flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. ‘The human element' is our crux and catalyst, driving all that we do, whether we're interacting with patients, providers, or practices. We're here to partner with those ready for a change. More than a compounding pharmacy, we're on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare. Location: Remote (USA) Position Type: Full-Time Position Summary The Pharmaceutical Content Compliance Manager supports Strive Pharmacy's informational content review program by ensuring all marketing, educational, and communication materials comply with applicable laws, pharmacy regulations, compounding standards, and internal policies before release. This role sits as a critical link at the intersection of Compliance, Clinical, Marketing/Communications, Brand, Sales, and Legal teams at Strive Pharmacy. The Manager will complete cross-functional reviews, set procedures, and advise on claim language and risk, ensuring alignment with federal and state requirements while enabling high-quality, on-brand communications. This role ensures that all content produced and released internally or externally by Strive Pharmacy is accurate, compliant, and aligned with FDA and FTC guidance as well as federal and state regulations. The Manager is also responsible to build the governance, workflows, and training that keep our content accurate, substantiated, and compliant across all channels (web, email, print, social, video, provider materials, patient education, packaging/labels, and point-of-care assets). The ideal candidate will combine deep regulatory expertise with a collaborative mindset, enabling Strive to maintain the highest standards of integrity while delivering engaging and compliant communications. Key Responsibilities Drive Compliance content review: Design, implement, and continuously improve Strive's content compliance framework (policies, SOPs, workflows, SLAs, and controls) for prescription, supplement, and OTC product lines. Train and support cross-functional teams on compliant content creation practices. Lead cross-functional review: Prioritize and manage content review requests based on business needs, deadlines, and risk. Triage, prioritize, and approve content. Provide early-stage guidance to accelerate cycles and reduce rework. Monitor queue and enforce SLAs. Claims & substantiation: Establish and maintain a compliant language library. Ensure appropriate qualifiers, disclaimers, and structure/function positioning for supplements. Prohibit unsubstantiated, misleading, comparative, or superiority claims. Participate in marketing/content planning meetings for upstream compliance. Regulatory alignment: Interpret and apply USP //, FDA and FTC advertising/promotion guidance, HIPAA (marketing permissions), and relevant state board requirements to real-world assets and campaigns. Understand and advise on compliant content and communication guidelines for all Strive products and services (prescription and OTC). Risk management: Provide timely and accurate guidance grounded in applicable laws. Stay ahead of evolving enforcement trends and emerging digital marketing risks. Monitor changes in industry or regulatory requirements impacting content. Training & enablement: Develop compliant content playbooks, training modules, and language guides for Strive teams. Upskill teams on compliant copy, fair balance, disclosures, testimonials, endorsements, and social media practices. Documentation & audit readiness: Build a content repository and auditable record of decisions, approvals, and rationales. Maintain documentation of all reviews and approvals for audit readiness. Prepare materials for inspections or external reviews. Metrics & reporting: Optimize review tools/queues (e.g., Asana). Support KPIs such as review volume, cycle time, first-pass approval rate, re-work rate, escalation frequency, and SLA adherence. Standardized processes to improve efficiency and accountability. Prepare executive-level dashboards and insights to drive continuous improvement. Collaboration with Legal/Privacy: Participate in meetings with internal and external legal counsel as needed. Partner to align on risk thresholds, required notices/permissions, patient data usage, and incident response in public channels. Inquiry response: Take ownership over responding to compliance inquiries originating from staff throughout the organization related to content compliance questions and issues. Respond to inquiries with detail, clarity, substantiation, and recommended action/direction for the requestor. Qualifications PharmD (required). JD or regulatory education preferred. 3+ years in pharmacy compliance, regulatory affairs, MLR/content review, or closely related roles within healthcare, pharmacy, biotech, or digital health industries. Direct experience in content and marketing review. Strong knowledge of USP //, FDA/FTC marketing/advertising guidelines (including digital, social, testimonials, endorsements, and disclosures), HIPAA marketing rules, and federal and state pharmacy requirements. Demonstrated ability to interpret complex regulations into actionable, scalable guidance and to make timely, defensible approval decisions under fast-paced deadlines. Track record of working cross-departmentally, training non-compliance stakeholders, and influencing outcomes without formal authority. Exceptional attention to detail and accuracy. Excellent writing/editing skills with precision on claims, qualifiers, and consumer-friendly risk language. Highly organized; excels at prioritization across multiple concurrent launches and deadlines. Proactive problem-solver who offers compliant solutions and can make sound, timely decisions. Ability to balance regulatory compliance with business objectives by guiding teams toward compliant alternatives that achieve marketing goals. Exceptional communication skills, both written and oral. Strong interpersonal skills with the ability to collaborate across departments and to educate and influence non-compliance stakeholders toward compliant solutions. Exceptional skills in time management and prioritization, and the ability to manage multiple concurrent priorities and deadlines in a fast-paced environment. Proven ability to review and approve content under tight deadlines without compromising quality or accuracy. Commitment to ongoing professional development and staying current with regulatory changes impacting pharmacy marketing. Experience in writing standard operating procedures (SOPs). Proficient with Google Workspace and Microsoft Office. Experience using Asana and Canva preferred. Travel: Occasional ( Annual Salary$120,000-$140,000 USDBenefits/ Perks Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members. Culture At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace. EEO Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws. Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.

The Regulatory Labeling Manager serves as a vital member of the MLR team, providing strategic, science-driven regulatory guidance to cross-functional teams. The role involves offering insights on promotional strategy, claim development, labeling alignment, and risk management. As a key regulatory thought partner, you will enable compliant communication of complex clinical and scientific data across Commercial and Medical leadership. Responsibilities + Serve as the Regulatory representative on the MLR team. + Independently review and approve promotional materials to ensure compliance with FDA regulations, product labeling, guidance documents, and internal policies. + Assess the impact of labeling changes on promotional strategy and ensure timely, compliant updates across all materials. + Support promotion of products in development, including accelerated approval and post-marketing commitment considerations. + Serve as primary liaison with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising & Promotional Labeling Branch (APLB). + Lead regulatory strategy and execution for OPDP submissions, including advisory comments, time-of-first-use submissions, Form 2253 filings, etc. + Monitor FDA enforcement trends, regulatory guidance, and biotech industry best practices; translate insights into internal guidance and training. + Partner closely with Medical Affairs, Clinical Development, Labeling, Legal, and Commercial teams to ensure consistent, accurate, and compliant messaging across channels. + Provide strategic regulatory labeling guidance to cross-functional teams. + Oversee the creation, revision, and maintenance of product labeling, including Core Data sheet, Prescribing Information (USPI), Medication Guides, Patient Package Inserts, and container labeling. + Ensure consistency and alignment between labeling content, clinical data, risk management activities, and promotional messaging. Essential Skills + 8-10+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry. + 5+ years of direct experience in Regulatory Advertising & Promotion. + Demonstrated experience supporting product launches and lifecycle experience with FDA advertising and promotion regulations. + Knowledge of FDA evidence standards for promotional claims, including interpretation of clinical trial data and scientific literature. + Excellent written and verbal communication skills and strong regulatory judgment. + Proficiency with regulatory and document management systems and Microsoft Office tools. Additional Skills & Qualifications + Bachelor's degree in a scientific, healthcare-related, business, or legal discipline. + Advanced scientific degree (MS, MD, PharmD, PhD) preferred. + Experience participating in Label Working Groups and supporting U.S. and global labeling strategies. Work Environment This is a remote, part-time position, offering flexibility and the ability to work from home. Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay and Benefits The pay range for this position is $90.00 - $150.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jan 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

SummaryThis role reports to the Global Head of Regulatory Affairs GE HealthCare's Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for GE HealthCare's Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives regulatory strategy for product development, submissions, approvals, and post-market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time-to-market. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description Key Responsibilities: Regulatory Strategy & Execution Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management. Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development. Agency Engagement Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries. Represent GE HealthCare PDx in regulatory meetings and industry forums. Cross-Functional Leadership Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies. Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials. Team Leadership Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables. Foster a culture of compliance, agility, and continuous improvement. Governance & Compliance Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers. Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements. Support budget planning for the Regulatory Affairs function. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets. Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components. Experience leading meetings with FDA and Health Canada. Background in sterile injectables; radiopharmaceutical experience is a strong asset. Desired Characteristics: Strategic thinker with strong analytical and problem-solving skills. Excellent oral and written communication; ability to influence and negotiate effectively. Proven leadership and team development capabilities. Strong project management and organizational skills; ability to manage complex priorities. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,000.00-$270,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: February 09, 2026

At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. This is a Remote position. Responsibilities include: · Act as the primary Regulatory expert within an assigned client's Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. · Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned product's lifecycle. · Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. · Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. · Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. Qualifications for this position include: · At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. · Ability to work independently in a remote role with minimal oversight.· Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. · Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. · Bachelor's degree (advanced degree in a science discipline preferred) As a part of our full-time team, you are eligible for our Comprehensive Benefits including: Medical, Dental and Vision Insurance Disability Insurance and Life Insurance 401(k) program with company match A balanced approach to work-life that offers a generous PTO program and Holidays. This is a remote position. Compensation: $170,000.00 - $210,000.00 per year We are 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, or any other characteristic protected by law. At Canopy, we help companies speed science from pipeline to people with end-to-end expertise and seamless support along the drug development journey. We provide both strategic and tactical solutions in the areas of MLR & Content Solutions, Medical Review, Medical Talent Solutions, Regulatory Affairs, Regulatory Operations, and Veeva Solutions. Together, we partner with our customers to deliver the on-demand expertise, technology, and service to catalyze their progress and get their product to the patients who need it, sooner. Our culture of one of empowerment, everyone in our company has a voice and plays a role in the success of the business and a role in developing our values and behavior. We recruit, train and develop people to ensure the very best for our client partners.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Manager, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Executive Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required. Essential Job Functions and Responsibilities: These may include but are not limited to: Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed. Act as a regulatory lead on a Phase 1, 2 or 3 clinical study Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization. Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications. Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, routine submissions, and amendments as needed. Develop and manage project timelines for regulatory submissions. Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions. Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages. Track submissions, correspondence, and commitments with health authorities. Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional. Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate. Conduct regulatory intelligence or research projects as required. Education and Experience: Required: Bachelor's or M.S./Ph.D. degree in scientific area. Minimum of 7 years' experience with a Bachelor's or 5 years' experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting. Minimum of 2 years supervisory experience. Equivalent combination of relevant education and applicable job experience may be considered. Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) requirements, and FDA regulations. Experience and knowledge in the preparation of regulatory submissions, i.e. US IND and/or NDA sequences. Ability to work both independently with direction and within project teams and see all projects through to their completion. Excellent written and oral communication skills. Strong organizational skills, including the ability to prioritize workload. Strong interpersonal skills and the ability to deal effectively with other people/departments. Ability to meet deadlines and perform multiple tasks in a fast-paced setting Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required. Preferred: Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful. Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization. Software Knowledge: Electronic document management systems use (e.g., Veeva) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc). Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $130000 - $157000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

At Sirona Medical, we're building software that enables physicians to work as fast as they can think. Each year in the U.S., billions of patient images are captured-and nearly all of them are reviewed and diagnosed by radiologists. These specialists are the central hub of diagnostic medicine: over 80% of all healthcare data flows through radiology IT systems. Yet despite their pivotal role, radiologists are overburdened by outdated, fragmented software which limits their efficiency and ultimately the quality and efficiency of care that health systems can provide patients. That's where Sirona comes in. We're a San Francisco-based, cloud-native software company with employees around the world. Our deep understanding of both the practice and business of radiology has allowed us to build RadOS-a unified, AI-powered operating system powering the entire radiology workflows. How Sirona Solves the Problem Sirona is uniquely positioned to transform the way radiology is practiced. We're delivering the organizational shift that both individual radiologists and entire practices urgently need: A unified, intuitive, and platform-agnostic solution A streamlined workspace that makes every part of the radiologist's workflow faster and easier The freedom to read from anywhere, for anyone By cutting clicks, optimizing diagnostic time, and unlocking efficiencies that extend far beyond the reading room into all care settings, Sirona empowers radiologists-and in doing so, we help the entire healthcare system move faster, smarter, and with greater impact on patient outcomes. For more information, please visit ******************************** The Regulatory Affairs Manager (“RAM”) at Sirona will help build a comprehensive, global regulatory system, support teams in executing quality and regulatory guidance, identify and resolve regulatory-related issues, and drive continuous improvement. This individual will lead the execution of cross-functional regulatory initiatives and serve as a key representative and partner to the VP of Regulatory Affairs and Quality Assurance. Key Responsibilities: Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner Leverage external regulatory firms to design regulatory strategies and lead internal execution Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed Define and execute required regulatory certifications and MDSAP plans Host internal audits and regulatory inspections in partnership with the VP of RAQA Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics Develop deeper regulatory and quality expertise through hands-on experience and mentorship Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions) Maintain a global regulatory watch and advise the business accordingly Key Requirements: 7+ years of medical device regulatory experience, preferably in software or technology-driven environments Working knowledge of FDA medical device regulations (Class I and/or II), EU MDR, and global regulatory standards, including ISO 13485 Strong organizational and communication skills, with the ability to produce clear, concise, and well-maintained documentation Experience conducting internal audits or supporting audit activities Experience hosting audits and regulatory inspections Ability to write, edit, and improve quality and regulatory procedures covering the full product lifecycle from pre-market through post-market Ability to create and deliver training materials for new or updated procedures Demonstrated ability to quickly learn and implement new quality management and regulatory standards A proactive self-starter with a positive, growth-oriented mindset Benefits Stock Options Medical, dental, vision insurance Life insurance Maternity and Paternity Leave Flexible time off 401K matching MacBook Pro Sponsorship for conferences, continuing education, etc. The annual US base salary range for this full-time position is $130,000 - $160,000 + equity + benefits. Pay scale is flexible depending on experience. Within the range, individual pay is determined by work location and additional factors, including job-related skills, competencies, experience, relevant education and training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Job TitleSenior Regulatory Affairs Manager- REMOTE Location(s) US Remote - CT, US Remote - FL, US Remote - GA, US Remote - MA, US Remote - NC, US Remote - NJ, US Remote - VA About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health. Find your future at Revvity Please note: This is a customer-funded position. Continued employment is contingent upon the availability of customer funding. Supports North America Regulatory activities Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, Develop North America regulatory strategies plan for submission for IVD products Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated Support CE marking activities for IVD products and other market clearance for products manufactured globally Review and approve promotional materials and product labeling Support importation/exportation permitting activities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time. Basic Qualifications: Bachelor's Degree in a STEM field 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) Preferred Qualifications: Travel as circumstances dictate Excellent understanding of regulations and guidance documents required in Americas region RAC certified Excellent interpersonal, verbal and written communication skills (in English) Excellent time management, organizational, negotiation, and problem-solving skills Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management Compensation range: The annual base salary range for this full-time position is $140-150,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, 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. Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered. #LI-CH1 What do we offer? We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits: Medical, Dental, and Vision Insurance Options Life and Disability Insurance Paid Time-Off Parental Benefits Compassionate Care Leave 401k with Company Match Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page. *For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information. Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.

Job Description WHO WE ARE The Edison Electric Institute (EEI) is the association that represents all U.S. investor-owned electric companies. Our members provide electricity for more than 220 million Americans and operate in all 50 states and the District of Columbia. As a whole, the electric power industry supports more than 7 million jobs in communities across the United States. EEI employees are required to work in office Monday-Thursday, and have the option to work remotely on Fridays. KEY RESPONSIBILITIES OF THE MANAGER, POLITICAL AFFAIRS: The Manager, Political and External Affairs plays a critical role in advancing EEI's federal political engagement strategy by supporting the Senior Director across three core areas: PAC fundraising, industry event management, and political programming. The Manager serves as the internal lead for PowerPAC fundraising, driving engagement from member companies. The Manager collaborates closely with the PAC Steering Committee and EEI leadership to meet annual fundraising goals, manage the PowerPAC budget, track performance, and ensure full compliance with all reporting requirements. The Manager also produces treasurer's reports, maintains donor and disbursement records, and provides background materials to support contribution decision-making. Other important responsibilities of the Manager, Political Affairs: Support the Senior Director in executing PowerPAC's fundraising strategy, helping to engage all eligible groups and member companies to meet annual fundraising goals. Assist in developing PAC campaigns, strengthening relationships, and identifying opportunities to expand PAC participation and visibility. Assist in managing the PowerPAC budget, including tracking fundraising totals, monitoring financial activity, preparing candidate disbursements, and supporting PAC Steering Committee operations. Prepare treasurer's reports and write detailed memos summarizing political background information, candidate assessments, and related analysis. Play a central role in planning and executing EEI's major political and industry events, ensuring operational excellence and strategic alignment with EEI's advocacy objectives. Provide operational, financial, and compliance support to the Senior Director, including processing invoices; coordinating with the General Counsel's office on contracts; and preparing materials for the semiannual LD-203 contributions report. Administer the charitable PAC match program, ensuring accuracy and timely processing on behalf of EEI employees who contribute to PowerPAC. REQUIRED & PREFERRED QUALIFICATIONS: A bachelor's degree in Political Science, Communications, Public Policy, or a related field is required. 6-8 years of experience in PAC management, political fundraising, political operations, or planning high-level political or industry events is required. Demonstrated ability to research, interpret, and analyze political trends and developments. Exceptional written and verbal communication skills with experience drafting policy briefs, analytical reports, and background materials for senior leaders, elected officials, or policymakers., Strong technical and administrative skills, including proficiency with Office 365 and Microsoft Office applications, and the ability to learn internal accounting and budgeting systems. Strong organizational skills and the ability to take initiative, manage competing priorities, and complete projects in a timely manner are essential. Travel requirement: 10%. COMPENSATION The salary range for role is $80,000-125,000. Starting annual salary will be determined on individual qualifications. We offer a competitive benefits package that includes medical, dental, vision, 401k, paid time off, tuition assistance, wellness incentives and programs, transportation subsidy, and professional development opportunities. The role is eligible for a performance based bonus for the 2026 calendar year which is paid out the following March. PHYSICAL AND SENSORY DEMANDS Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EEI is committed to providing a productive and safe environment. To achieve that goal, we conduct background and reference check investigations for all final applicants being considered for employment. Equal Opportunity Employment M/D/F/V.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Clinical Compliance Manager(Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You'll Make in this Role As a Clinical Compliance Manager you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Providing leadership and oversight for the team responsible for authoring and maintaining clinical evaluation documentation, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and associated processes. Allocating resources and monitoring timelines to ensure deliverables meet regulatory and business needs, and managing this process across the entire Dental Solutions product portfolio. Authoring and coordinating clinical evaluations for new products and legacy devices. Collaborating with cross-functional teams to generate a clinical evaluation that collects, analyses and assesses the clinical data pertaining to a medical device to verify the safety and performance in compliance with applicable regulations. Owning and continuously improving the clinical evaluation process, including developing SOPs, templates, and best practices for clinical evaluation documentation. Acting as the primary point of contact for audits and regulatory inspections related to clinical evaluation. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND seven (7) years of experience in the medical device industry Strong knowledge of EU MDR, MEDDEV 2.7/1 and clinical evaluations, including 5 years of experience medical writing according to EU MDR or comparable experience. 2+ years of experience managing teams and complex documentation processes. Additional qualifications that could help you succeed even further in this role include: Dental experience in a private, public, government or military environment. Ability to work effectively in cross-functional and cross-cultural teams. Strong understanding of global regulatory requirements for medical devices. Excellent organizational, leadership, and communication skills. Proven strength in clinical and medical writing. Ability to manage multiple complex projects simultaneously. Strategic thinking, critical thinking, reasoning, and interpretive skills Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills. Ability to leverage AI technologies to strategically optimize team workflows, drive automation of key processes, and elevate operational efficiency across the team. Work location: Remote - United States Travel: May include up to 10% domestic Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $160,284 - $195,903, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.

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.

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: Responsible for the development and successful execution of regulatory strategies, plans and processes for assigned projects and/or products with considerable technical complexity and diversity requiring impact on internal decision making. The assigned area responsibility may be focused on global and/or regional development compounds and new indications / formulations of commercial products and/or life cycle management of commercial products within a within a region. Responsible to be a Regional Regulatory lead or Global Regulatory Lead, for development programs (early stage of clinical development), or as a regulatory representative for commercial products requiring multifaceted problem solving and internal decision making. Collaborates to assure global and local regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures Astellas' programs meet all applicable regulatory and business requirements. Provides regional input and ensures regional alignment with regulatory strategies for global programs and products. Responsible for interacting with global and regional peers and regulatory management to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches and interacts with regulatory agencies. Accountable for project-related and marketed product-related communications and interactions with project and/or product team members, regulatory authorities and health agencies requiring impact on decision making; incorporates regulatory environment trends to ensure the projects/products reflect up-to-date regulatory strategies. May lead an Extended Regulatory Team including Regional Regulatory Leads and other GRA professionals across regions and functions to develop and implement regulatory strategies and accomplish project/product objectives for global and/or regional products. Advises project/product teams in the application of regulatory strategies and solving of regulatory issues. Collaborates with Astellas GRA TA Heads and regions on global regulatory strategies and with Astellas functions for regional programs and products. Responsibilities and Accountabilities: Regulatory Excellence Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as MAA, NDA and variations associated with early-stage development programs, development of new indications / formulations and/or commercial products and is accountable for the expert review of major deliverables from a regulatory perspective. Leads regulatory development in GRL or regional regulatory lead roles in the context of Development TAs and Core Teams and Regulatory Extended Teams for programs with considerable complexity requiring impact on internal and external decision making. Applies understanding of regulatory requirements and trends into the development of aligned regulatory strategies. Develops and contributes to the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals. Accountable for the preparation and submission of technical documents to regulatory authorities for assigned projects/products. Ensures data summaries from research, development, and manufacturing reports are adequate in content, quality, interpretation and regulatory/scientific rigor to drive success with regulatory authorities and builds consistency in the messaging of data globally. Responsible for execution of the regulatory strategy into regulatory applications (i.e. Scientific Advice, IND, MAA, NDA, BLA and variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards and Astellas SOPs and are executed on time. Ensures viable strategies are established for regulatory applications. Collaborates with GRA management to provide oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities and similar experts and bodies. Guides Extended GRA team members, Regional Regulatory Leads or other GRA staff in a matrix organization on regulatory and decision-making issues. Shares relevant information and drives development of viable strategies and/or methodologies which reflect up-to-date regulatory and compliance standards. Identifies and escalates where appropriate to resolve significant issues and risks. Provides regulatory expertise for planning, approving regulatory content. Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and contributes to the preparation of recommendations and robust opinions for management in a timely manner. Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues. May provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA. Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products. Builds and maintains good relationships with Regulatory Authorities. Organization & People Management Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, Global Medical Development, Technology/PPM and Astellas (e,g, GMS, regional commercial businesses, Medical Affairs, Legal, affiliates, etc). Represents GRA within project/product teams and collaborates with global Astellas stakeholders to affect global strategies and consistency in regulatory messaging.

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description Required: (Remote Opportunity - Temp to Perm) • The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. • In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. • The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. • Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters. Key responsibilities: • Lead Regulatory Associates or Specialists in addition to work as an individual contributor • Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions) • Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. • Develop Regulatory Strategies for new or modified products and prepare project plans & budgets. • Monitor and provide management with impact of changes in the Regulatory environment. • Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. • Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. • Support Design Control process. • Prepare Rational to file documentation for modifications to devices when appropriate. • Participate in FDA & other notified body Inspections. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain Regulatory impact for external and internal documents. • Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. • Review promotional material and labeling for regulatory compliance. Qualifications Required qualifications:(Remote Opportunity) • Bachelor's degree required. Scientific or engineering field preferred. • 5+ years of medical device regulatory affairs experience. • Must have authored 510(k) submissions • Must have knowledge of U.S. FDA regulations and standards • 3+ years of experience interacting with FDA and/or other regulatory agencies • Experience with devices containing software is strongly preferred. • Must work well in team environments • Must demonstrate leadership skills in team setting. • Proven analytical abilities • Solid understanding of manufacturing and change control, and an awareness of regulatory trends Additional Information To know more on this position or to schedule an interview, please contact; Ujjwal Mane ************ ujjwal.mane[@]collabera.com

BRIE is more than insurance - it's a promise BRIE, short for Builder Reciprocal Insurance Exchange, is the go-to solution for homeowners seeking reliable home insurance coverage in new- or newer-home communities. As a reciprocal exchange, BRIE operates differently. Unlike traditional insurance models that focus on profits for shareholders, a reciprocal exchange is member-focused-designed to serve its subscribers over the long term. Working at BRIE means being part of a mission-driven organization that emphasizes standing together in times of need. It's an opportunity to contribute to an innovative and expanding insurance model rooted in community and long-term value. We are seeking a highly skilled and experienced Compliance professional for the Builder Risk Management, LLC, to lead compliance operations for the Builder Reciprocal Insurance Exchange (BRIE), a newly established reciprocal insurance exchange dedicated to providing builder sourced homeowner insurance nationwide. BRIE operates as a member-focused exchange, with Millennial Specialty Insurance, LLC as its insurance service provider. The ideal candidate will bring deep expertise in Property & Casualty insurance compliance, strong analytical skills, effective communication abilities, and a thorough understanding of regulatory frameworks in the insurance industry. This role will oversee compliance functions across multiple operations, ensuring adherence to state and federal regulations while fostering a culture of compliance excellence. Key Responsibilities Regulatory Compliance Oversight Monitor and communicate legislative and regulatory changes. Ensure the company complies with all applicable laws, regulations, and internal policies by timely adopting new requirements. Oversee regulatory reporting to insurance departments and other compliance functions including, but not limited to, the following: Consumer Complaint Handling; Regulatory Exams & Investigations (including Market Conduct Exams); Regulatory Inquiries & Communications; Homeowners Data Calls; NAIC Market Conduct Annual Statements; Coordination of financial reporting requirements; and Medicare Secondary Payer compliance, including Section 111 reporting; Policies, Procedures, & Program Development Create, update, and enforce compliance policies and procedures to mitigate risks and ensure adherence to regulations. Support the adoption and adherence to corporate governance procedures and best business practice guidelines. Develop, organize, and deliver compliance training programs to communicate key regulatory changes and compliance responsibilities. Strategic Initiatives & Risk Management Identify, assess, manage and mitigate compliance risks by developing and implementing internal controls and procedures. Support and manage complex strategic planning and projects. Conduct regulator internal reviews/audits to assess compliance with regulations and prepare reports for leadership. Firm-wide Collaboration Work closely with various departments to ensure compliance activities are integrated into business processes and operations. Partner with cross-functional and cross-organizational teams, including Legal and Operations, to support regulatory requirements for BRIE. Serve as a strategic advisor on regulatory requirements, filings, and industry trends. Report key compliance metrics and risk assessments to senior leadership. Qualifications 7+ years in Property & Casualty insurance compliance. In-house carrier experience required. Strong understanding of NAIC model laws, state-specific regulations, and compliance frameworks. Exceptional communication, analytical, and problem-solving abilities. Adept at process improvement and technology-driven compliance solutions. Bachelor's degree required. Juris Doctor degree and compliance certifications (e.g., CRCM, CCEP) preferred. High ethical standards, sound judgment, and ability to influence decision-making at senior levels. #LI-BM1 #LI-REMOTE Click here for some insight into our culture! The Baldwin Group will not accept unsolicited resumes from any source other than directly from a candidate who applies on our career site. Any unsolicited resumes sent to The Baldwin Group, including unsolicited resumes sent via any source from an Agency, will not be considered and are not subject to any fees for any placement resulting from the receipt of an unsolicited resume.

About PHOENIX PHOENIX Retail, LLC is a retail platform operating the Express and Bonobos brands worldwide. Express is a multichannel apparel brand dedicated to a design philosophy rooted in modern, confident and effortless style whether dressing for work, everyday or special occasions. Bonobos is a menswear brand known for being pioneers of exceptional fit and a personalized, innovative retail model. Customers can experience our brands in over 400 Express retail and Express Factory Outlet stores, 50 Bonobos Guideshops, and online at *************** and **************** About Express Express is a multichannel apparel brand dedicated to creating confidence and inspiring self-expression. Since its launch in 1980, the brand has embraced a design philosophy rooted in modern, confident and effortless style. Whether dressing for work, everyday or special occasions, Express ensures you look and feel your best, wherever life takes you. The Company operates over 400 retail and outlet stores in the United States and Puerto Rico, the express.com online store and the Express mobile app. Responsibilities The Foreign Trade Zone (FTZ) Compliance Manager is the subject matter expert responsible for all aspects of operating a zone and initiatives to streamline the import process to maintain compliance with import regulations within the ICRS system. This role will be responsible for establishing control-related standards, strict adherence to CBP's ICRS requirements, and CTPAT Security requirements, including maintaining accurate physical/digital inventory records, and managing the flow of merchandise into and out of the zone to optimize duty deferral and operational efficiency. In addition, the manager will also be responsible for the FTZ systems (ICRS), including maintenance, troubleshooting, and enhancements. The FTZ Compliance Manager will need to have deep institutional knowledge and understanding of the Foreign-Trade Zones Board regulations, and the Customs regulations, and how these apply to and impact the FTZ operations. KEY RESPONSIBILITIES FTZ Operational * End-to-end management of zone processes, including zone transfers. * Responsible for updating and maintaining FTZ Procedures Manual, Process Flows, and SOPs. * Manage the execution and filing of all required CBP forms for merchandise admissions (CBPF 214) and removals for consumption (CBPF 3461/7501). * Maintain FTZ files and retain FTZ records as required by law and regulations. * Responsible for monitoring the savings associated with the FTZ operations. * Create periodic FTZ reports (Quarterly HMF, Yearly Blanket CBP form 216, Annual Reconciliation, Certification Letter, FTZ Board Report, etc.). * Coordinate with Finance regarding payment of quarterly HMF payments, and FTZ Operator bond premium. FTZ Data Analytics & Reconciliation * Oversee real-time inventory tracking within the WMS/ICRS and conduct regular, documented cycle counts and physical inventory reconciliations. * Implement daily automated inventory reconciliation processes. * Investigate and resolve inventory imbalances. * Perform root cause analysis on systemic issues. * Analyze data to create FTZ metrics and KPIs to identify areas of risk and opportunities. Compliance & Regulatory Oversight * Oversee admission and entry documentation accuracy. * Process reconciliation, and post admission corrections within the defined time limits. * Support CBP audits and examinations. * Maintain FTZ recordkeeping requirements. * Support the international trade team with adherence to compliance policies and procedures, in achieving operational objectives, and in fostering a culture of compliance. * Ensure the FTZ facility adheres to all CTPAT physical security standards and manage security incident response planning. * Monitor Customs/Regulatory environment changes and adjusting procedures as required. Vendor & Stakeholder Management * Oversee outsourced FTZ operational partners. * Monitor vendor performance and SLA compliance. * Interface with warehouse operations teams. * Manage escalations and issue resolution. * Partner with internal stakeholders to identify process improvements and implement solutions. * Maintain relationship with FTZ Board, and Grantee. * Maintain a positive working relation with US Customs and Border Protection. * Serve as liaison with other functional areas within the organization and external partners to ensure the information systems are maintained, updated and accurate for FTZ reporting and compliance purposes. * Work with cross functional teams on strategic initiatives to reduce spend and optimize FTZ capabilities. * Assist in internal and external training. Process Improvement & Risk Management * Lead internal FTZ audit activities to identify and correct compliance issues and minimize risk. * Leverage technology and data to streamline processes and improve efficiency. * Identify process gaps causing inventory imbalances. * Create risk mitigation strategies. * Implement best practices for FTZ operations. * Support continuous improvement initiatives. REQUIRED EXPERIENCE & QUALIFICATIONS Education: * Bachelor's degree in international trade, supply chain, or the equivalent combination of education plus experience. Experience: * 5+ years of experience in Foreign Trade Zone operations and trade compliance, experience with FTZ warehouse transitions beneficial. 3+ years in data analytics or inventory management. * Experience with ERP systems like SAP or Oracle to manage inventory movement. * Experience using Inventory Control and Recordkeeping Systems (ICRS). * Background in vendor management preferred Knowledge: * Strong understanding of FTZ regulations (19 CFR 146). * Knowledge of import entry process with CBP and other government agencies. * Knowledge of apparel importing preferred. * Proficiency in data analytics is preferred. * Certified Customs Specialist and/or a Customs Broker's License is beneficial. CRITICAL SKILLS & ATTRIBUTES Technical: * Inventory Control Expertise * Advanced problem-solving and root cause analysis * Data analysis and reporting skills * Variance detection and reconciliation * Process mapping and optimization Leadership Abilities: * Ability to work independently and build from ground up * Change management capabilities * Vendor oversight and negotiation skills * Cross-functional influence without direct authority * Strategic thinking with tactical execution Communication: * Ability to translate data into actionable insights * Clear and concise documentation and reporting * Vendor relationship management Personal Attributes: * Meticulous and Detail-Oriented * Self-directed and proactive * Adaptable and effective in a transitional environment * Collaborative approach * Strong organizational skills * Continuous improvement mindset Closing If you would like to know more about the California Consumer Privacy Act click here. An equal opportunity employer, PHOENIX does not discriminate in recruiting, hiring or any other terms and conditions of employment hiring on the basis of any federal, state, or locally protected characteristic. PHOENIX only hires individuals authorized for employment in the United States. PHOENIX is committed to providing reasonable accommodation to individuals with disabilities. If you need an accommodation to search and apply for a job position due to a disability, please call ************** and say 'Associate Relations' or send an e-mail to ****************************** and let us know the nature of your request and your contact information. Notification to Agencies: Please note that PHOENIX does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, PHOENIX will not consider or approve payment to any third-parties for hires made.

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, FinanceExternal 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 Director, Governance, Risk & Compliance leads a team of analysts to build and maintain an effective GRC program at NextGen Healthcare. The ideal candidate will collaborate closely with the rest of the Information Security department, along with Product, R&D, and Engineering teams to define and partner on appropriate security controls across NextGen products and systems, including NextGen SaaS offerings and platforms. This team will also have responsibility for NextGen Healthcare's Security Governance and various regular Certification cycles and partnering with Legal on Information Security related contracts and requirements. Establish IT audit procedures relevant to HITRUST/HIPAA, ISO 27001, SOC 2, and other data protection or privacy-related regulations Provide governance and security oversight around the company's adoption and use of AI, LLMs, and other generative-AI capabilities Evaluate and test the design and operating effectiveness of technical and administrative security controls Maintain and manage the Third-Party Risk Management program and integration with Vendor and Customer related Security obligations, requirements, and contractual agreements Work closely with the CISO to develop and implement strategies for governance and compliance related to corporate-wide security initiatives Design and implement data protection policies, process and procedures to align with HIPAA and Information Security policies, especially for cloud-hosted data environments and customer data handling throughout the development lifecycle Implement and manage an Identity Governance Program to ensure appropriate authorization to key resources, including the development of a Role Based Access Control and Role Review process. Develop training programs and FAQs related to data protection, privacy and secure data handling procedures Provide oversight and guidance for periodic security assessments to ensure compliance with information security policies and established security controls Develop metrics and compliance dashboards to measure progress for security initiatives and communicate team accomplishments and the effectiveness of audited security controls and processes Maintain and mature the Risk Register, Policy Exception Tracking, and Security Dashboard processes, standards, and components Ensure applications, networks, systems, cloud services, people, and process are assessed, monitored and audited in accordance with security controls related to SOC 2, ISO 27001, HITRUST/HIPAA and the corporate Information Security Policy Work closely with cross-functional teams to ensure security controls have been designed effectively and are working as intended Identify control deficiencies and weaknesses and recommending remediation plans for improvements Create, manage and hold staff accountable for corrective action plans (CAPs) Implement a process for continuous improvement of IT controls Work with internal and external resources to conduct and manage an assessment program for compliance requirements, including auditing and monitor privileged access to critical information systems; authentication and authorization processes; change control processes and IT operations processes Work closely with the Engineering teams to automate monitoring and auditing to reduce manual effort required for compliance activities Develop communication plans for executive-level reporting Lead the team in the development and evolution of security roadmaps, embodiment of strategic plans, understanding controls and process gaps, providing architectural vision, and enabling the larger information security team. Hire, grow and retain team members to expand the team and its capabilities within the organization. Perform assessments of security tools, vendors, and solutions to support information security roadmap initiatives Act as an advocate for mentoring and technical career growth in the information security organization Act as a liaison with other internal NextGen teams or driving new capabilities, product investments, and research to fill coverage gaps. Provide assistance and guidance to Sales and Support teams across various customer engagements. Regularly provide key performance and risk indicator metrics for management visibility into the status, health, and maturity of the Information Security Program at NextGen. Education Required: Bachelor's degree in Computer Science, Programming, Engineering, or similar field. Or, any combination of education and experience which would provide the required qualifications for the position. Experience Required: 4+ years of experience in Information Security with an emphasis on IT audit, IT risk management and/or IT compliance. Prior experience with managing a GRC team. Extensive background in information security services and operations and the people, process, and technology components. Significant experience in fulfilling business needs through the development of solutions through well-organized processes. Experience in client-facing discussions with new and existing customers to discuss security controls and implementations. Significant Service Management and or vendor management experience. License/Certification Required: Appropriate certifications a plus. Knowledge, Skills & Abilities: Knowledge of: Knowledge of technical security control environments and compliance frameworks including CSA CCM, ISO 270001 and SOC 2, HITRUST/HIPAA and GDPR. Skill in: Excellent analytical, technical and internal audit skills. Excellent organizational and documentation skills. Strong project management skills highly desired. Ability to: Proven ability to manage priorities & deadlines and to work independently in a highly dynamic and diverse environment with multiple concurrent projects happening simultaneously. The company has reviewed this to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. NextGen Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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.