Regulatory compliance manager work from home jobs - 134 jobs

About Axiom: Axiom is transforming the legal services landscape by delivering innovative solutions ranging from individual secondees to fully integrated project teams that combine top-tier talent with cutting-edge technology. Join our innovative talent community and help drive impactful legal solutions to complex problems in various industries. Job Description: We are seeking a Regulatory Compliance Manager to join our Insurance Compliance team. This role is responsible for leading and managing regulatory compliance operations across assigned operating units, with a primary focus on Medicare Secondary Payer (MSP) compliance. The ideal candidate will bring deep experience in commercial insurance compliance, strong leadership capabilities, and the ability to collaborate across geographically dispersed teams in a fast-paced, enterprise environment. Responsibilities: Lead and oversee a sustainable, enterprise-wide Medicare Secondary Payer (MSP) compliance program, including: Evaluating and maintaining Medicare Responsible Reporting Entity (RRE) IDs Managing claims data collection and reporting across multiple claims systems Monitoring reporting accuracy, error rates, and corrective actions Implement and maintain processes for: Creation and ongoing management of RRE IDs Training, guidance, and oversight to ensure personnel awareness of MSP data collection and reporting requirements Ensure segment teams, operating units, and corporate leadership receive timely and accurate information regarding: Medicare reporting activities Compliance deficiencies Corrective action plans Monitor legal and regulatory developments related to MSP compliance and update the compliance program accordingly Conduct regular meetings with segment teams, operating unit personnel, and corporate leadership to: Maintain effective working relationships Assess program understanding Identify areas for improvement and implement action plans Effectively communicate new legislation and regulatory requirements impacting the business Collaborate on and support enterprise-wide initiatives related to in-scope compliance work Assist with other Corporate Compliance responsibilities as assigned Minimum Qualifications: Bachelor's degree required; Juris Doctor (JD) or equivalent strongly preferred 7+ years of commercial insurance experience 7+ years of compliance-related experience, including MSP compliance Demonstrated experience managing Medicare Secondary Payer compliance programs Ability to lead teams with varied backgrounds across multiple locations Strong analytical skills with the ability to exercise sound professional judgment Must possess prior experience working within P&C insurance industry Preferred Skills: Professional compliance or insurance-related designations Experience using legal and regulatory research platforms such as Westlaw, LexisNexis, or Wolters Kluwer Prior experience working in enterprise or multi-operating-unit environments Proficiency in Microsoft Office (Word, Excel, Outlook, Teams, SharePoint) Highly detail-oriented, organized, and able to meet time-sensitive deadlines Strong written and verbal communication skills Ability to work independently with minimal supervision Proven people-management and leadership skills Comfortable operating in project-based, fast-paced environments Willingness to travel occasionally as required Compensation, Benefits & Location: This role offers a range of competitive compensation starting at $130,000 and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits, 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence. Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today's business landscape with best in breed alterative legal services. Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom's legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Learn more about working at Axiom. Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at ********************* and include "Applicant Accommodation" in the subject line. Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at **************************************** Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge. #LI-AG1

The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function. Essential functions of the job include but are not limited to: Provides regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required. Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers Works within a project team, and where necessary, leads project for the region or globally Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Assist in development of Regulatory Affairs Specialists and other operational area staff, as required Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides ICH GCP guidance, advice and training to internal and external clients Serve as representative of Global Regulatory Affairs at business development meetings Qualifications: Minimum Required: Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline Computer literacy (MS Office/ Office 365) Fluent in English Preferred: Graduate, postgraduate Possesses basic understanding of financial management Other Required: 5 + years or more relevant regulatory affairs experience Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays Competencies Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment Motivates other members of the project team to meet timelines and project goals Flexible attitude with respect to work assignments, and new learning Resolves project related problems and prioritize workload to meet deadlines with little support from management Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Collects data of consistently high standard Communicates both verbally and in written form in an acceptable manner Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$106,000-$151,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Blockchain.com is connecting the world to the future of finance. As the most trusted and fastest-growing global crypto company, it helps millions of people worldwide safely access cryptocurrency. Since its inception in 2011, Blockchain.com has earned the trust of over 90 million wallet holders and more than 40 million verified users, facilitating over $1 trillion in crypto transactions. As the US Regulatory Compliance Manager, you will be the architect and leader of our US regulatory strategy. This is a cornerstone position responsible for navigating the complex federal and state regulatory landscape to enable our continued growth and innovation. You will own the company's licensing roadmap, serve as the primary relationship manager with regulators, and provide strategic guidance that embeds compliance into the fabric of our products and operations. Your work will be critical to securing the company's long-term success and trustworthiness in the market. WHAT YOU WILL DO Regulatory Strategy & Leadership: Develop, implement, and manage the company's comprehensive US regulatory compliance program. Licensing Execution: Spearhead the company's state-by-state licensing strategy, with a primary focus on obtaining and maintaining Money Transmitter Licenses (MTLs). This includes managing applications, renewals, surety bonds, and required reporting across all relevant jurisdictions. Regulatory Engagement: Serve as the primary point of contact and cultivate strong, proactive relationships with federal and state regulators, including FinCEN, OCC, and state banking departments. Manage all regulatory examinations, inquiries, and correspondence. Product Compliance Advisory: Partner directly with Product, Engineering, and Business leadership to provide proactive regulatory guidance on new products and initiatives. Ensure a “compliance-by-design” approach, translating complex regulatory requirements into actionable product specifications. Reporting: Provide regular, clear reporting on the status of the compliance program, risk exposure, and key regulatory developments to the executive team. WHAT YOU WILL NEED 7 years of regulatory compliance experience within the financial services or fintech industry. Demonstrated, hands-on experience with the US Money Transmitter Licensing (MTL) framework, including application, maintenance, and reporting processes. Deep subject matter expertise in BSA/AML, KYC/CIP, and OFAC sanctions programs. Proven ability to interpret and apply complex financial regulations to innovative products and business models. What we'd love to see (Preferred Qualifications): Juris Doctor (J.D.) or a relevant advanced degree (e.g., MBA). Direct experience with cryptocurrency or digital asset compliance programs. Experience in a high-growth technology company environment. Established relationships and direct interaction experience with key state and federal financial regulators. Professional certifications such as CAMS (Certified Anti-Money Laundering Specialist) or CRCM (Certified Regulatory Compliance Manager). COMPENSATION & PERKS Competitive full-time salary based on experience and meaningful equity in an industry-leading company This is a role based in our Dallas office, with a mandatory in-office presence four days per week. The opportunity to be a key player and build your career at a rapidly expanding, global technology company in an exciting, emerging industry. Performance-based bonuses Apple equipment provided by the company Work from Anywhere Policy: You can work remotely from anywhere in the world for up to 20 days per year. Blockchain is committed to diversity and inclusion in the workplace and is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, religion, color, national origin, gender, gender expression, sex, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, and apprenticeship. Blockchain makes hiring decisions based solely on qualifications, merit, and business needs at the time. You may contact our Data Protection Officer by email at ******************. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities *Open to hiring in North America and LATAM only with no sponsorship needs. *Please submit CVs in English Key Responsibilities Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content. Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development. Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification. Training and oversight of additional FSP resources for artwork management Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities. Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs. Participate in cross-functional meetings to support product launches, labeling updates, and change control processes. Support continuous improvement initiatives related to artwork review processes and labeling systems. Required Knowledge/Skills Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH). Detail-oriented with excellent proofreading and quality control skills. Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko). Familiarity with proofreading tools (e.g., TVT, Global Vision). Ability to work independently and collaboratively in a fast-paced environment. Strong communication and organizational skills. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Anchorage Digital, we are building the world's most advanced digital asset platform for institutions to participate in crypto. Anchorage Digital is a crypto platform that enables institutions to participate in digital assets through custody, staking, trading, governance, settlement, and the industry's leading security infrastructure. Home to Anchorage Digital Bank N.A., the first federally chartered crypto bank in the U.S., Anchorage Digital also serves institutions through Anchorage Digital Singapore, Porto by Anchorage Digital, and other offerings. The company is funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion. Founded in 2017 in San Francisco, California, Anchorage Digital has offices in New York, New York; Porto, Portugal; Singapore; and Sioux Falls, South Dakota. Learn more at anchorage.com, on X @Anchorage, and on LinkedIn. We're building something truly unique here at Anchorage Digital. As the only federally chartered digital asset bank in the United States, we sit at the intersection of traditional banking and the rapidly evolving world of digital assets. Our transaction monitoring team plays a critical role in that mission: protecting the integrity of the financial system while supporting innovation in a space that's redefining how money moves. Joining our team means being part of a first-of-its-kind institution where your work will directly shape the standards for compliance and risk management in digital finance. You'll collaborate with experts across banking, technology, and crypto to design and refine monitoring strategies that go beyond the playbook of traditional financial institutions. Every decision you help make has real impact. Not just for our clients, but for the broader industry. If you're looking for an opportunity to be on the cutting edge, to bring creativity and rigor to solving complex problems, and to help set the tone for how digital assets and banking coexist responsibly, this is the place to do it. We're not just monitoring transactions. We're helping write the future of finance Technical Skills: Demonstrates extensive knowledge and experience with the tools used by the transaction monitoring team, and is able to speak to them at a high level with senior management. Demonstrates experience in identifying gaps in team workflows and procedures, raising awareness to leadership with suggestions on how to properly address the gaps and ensure proper procedures are followed, updated, and training conducted within and outside of the team, as appropriate. Complexity and Impact of Work: Provide feedback to direct leadership on methods or systems used by the team, or outside of the team, having the ability to navigate roadblocks and obstacles that may come up, and escalating when blocked. Manage transaction monitoring alerts and disposition workflows. Ability to work independently with good time management skills, managing multiple tasks assigned with little to no direction, only requiring work to be reviewed at critical points. Ability to conduct Quality Assurance/Quality Check reviews of L1 Analyst reviews. Assist the team in tuning exercises, as well as implementation of monitoring rules to prevent and detect money laundering, fraud or other financial crime responding to emerging trends. Is a prolific contributor of high quality who makes impactful contributions to the team, and identifies opportunities for improvement. Consistently demonstrates on-time delivery and high quality work product. Where a deadline or commitment is at risk, escalates to manager to help manage priorities, if appropriate, and alerts affected stakeholders so "no surprises." Organizational Knowledge: Is aware of the strategy of Anchorage Digital to guarantee its successful implementation and is considered when defining the planning and goals of the team. Has a deep understanding of the team's objectives and works with leadership to ensure regulatory compliance is being met. Ensures that knowledge is shared amongst the transaction monitoring team and does not position themselves or others as a single point of failure. Communication and Influence: Promotes positive working environments for inside and outside of the team with proper listening, speaking and empathy with colleagues, as well as embodies as a role model of our culture pillars. Works closely with the team in order to solve problems and assist or guide other members in processes or workflows within their area of specialization or domain, helping others understand the strategic goals of Anchorage and how their work relates to these. Uses expert judgment, insight, recommendations, conclusion, and ideas on how to improve the team (e.g., workflows, inventory, etc.) Consistently expresses clear, thoughtful, analytical and solutions-oriented communications, whether in high-impact slides/decks, written communications in slack or email, or verbal communications. You may be a fit for this role if you have: Experience in BSA/AML transactional review for institutional and retail clients Knowledge in BSA/AML and/or Sanctions regulations + Fraud Typologies Expertise in using blockchain analytics tools to disposition transaction monitoring alerts, preferably at a Bank or regulated Exchange A passion for building out programs in their early stages, including creation and maintenance of policies, procedures, and new tools A proven track record of being able to work independently A strong attention to detail Highly curious and a fast learner Although not a requirement, bonus points if: You were emotionally moved by the soundtrack to Hamilton, which chronicles the founding of a new financial system. :) You have expertise in data analytics and/or spreadsheet pivots/formulas for data analysis Blockchain Analytics Certifications (TRM, Chainalysis, etc.) Fraud Certifications About Anchorage Digital: Who we are The Anchorage Village, what we call our team, brings together the brightest minds from platform security, financial services, and distributed ledger technology to provide the building blocks that empower institutions to safely participate in the evolving digital asset ecosystem. As a diverse team of more than 600 members, we are united in one common goal: building the future of finance by providing the foundation upon which value moves safely in the new global economy. Anchorage Digital is committed to being a welcoming and inclusive workplace for everyone, and we are intentional about making sure people feel respected, supported, and connected at work-regardless of who you are or where you come from. We value and celebrate our differences and we believe being open about who we are allows us to do the best work of our lives. Anchorage Digital is an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. Anchorage Digital considers qualified applicants regardless of criminal histories, consistent with other legal requirements. “Anchorage Digital” refers to services that are offered either through Anchorage Digital Bank National Association, an OCC-chartered national trust bank, or Anchorage Lending CA, LLC a finance lender licensed by the California Department of Financial Protection and Innovation, License No. 60DBO-11976, or Anchorage Digital Singapore Pte Ltd, a Singapore private limited company, all wholly-owned subsidiaries of Anchor Labs, Inc., a Delaware corporation. Protecting your privacy rights is important to Anchorage Digital, and we work to maintain the trust and confidence of our clients when handling personal or financial information. Please see our privacy policy notices here.

Business Unit: Global Regulatory Affairs Execution Team Employment Type: Contract Duration: 6+ months (with possible extensions) Rate: $46 - $50 /hr. W2. Posting Date: 6/27/2024. Notes: Only qualified candidates need apply. Fully remote. Approximately 30 hours per week. 3 Key Consulting is hiring! We are recruiting an Regulatory Writing Manager for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Day to day activities include: Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance Ensure quality of regulatory submission documents at all stages of development Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and cross-departmental initiatives Top Must Have Skill Sets: Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types. Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Basic Qualifications: Doctorate degree Or Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications: Masters or higher degree in biology, chemistry, or other scientific field 5+ years in writing clinical and regulatory documents Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong written/oral communication skills and attention to detail Understanding and application of principles, concepts, theories, and standards of scientific/technical field Strong time and project management skills, engaging approach, and perseverance with a drive for results Leadership skills and ability to guide and influence the work of others Strong leadership in a collaborative team environment Why is the Position Open? Supplement additional workload on team Interview Process: Phone screens and video conference We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team

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.

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.

Join us for an exciting career with the leading provider of supplemental benefits! Our Promise Through skill-building, leadership development and philanthropic opportunities, we provide opportunities to build communities and grow your career, surrounded by diverse colleagues with high ethical standards. The Compliance Manager is part of the Audit and Corrections team and will be responsible for overseeing audit and corrective action engagements, providing guidance and training to audit staff, and ensuring compliance with auditing standards. This role will report to the Compliance Director, Correction and is part of the Avesis Compliance Department. The Compliance Department plays a pivotal role in ensuring that Avēsis adheres to federal and state regulations, as well as internal policies. It is responsible for preventing, detecting, and correcting compliance risks that could impact the Avesis' operational effectiveness as well as legal and reputational standing. The Compliance Department works to promote a culture of ethics, transparency, and accountability across the enterprise, making sure that all employees understand their responsibilities and the importance of adhering to legal, regulatory and compliance standards. Additionally, it provides ongoing training and resources to help staff stay informed about regulatory updates and best practices. Avēsis is an ancillary insurance company that guides members and communities to wellness through innovative, multidimensional, tailored offerings, delivered with a personal touch. We envision a world where lives are lived more fully, communities are healthier, and futures are brighter for all. To be successful at Avēsis, we perform at a high level everyday while remaining humble, helpful, and positive. Our high expectations are not for everyone. But for those of us who deeply care about the human condition and have a passion to improve lives, this is a place to thrive. Job Summary: The Compliance Manager is responsible for ensuring that audit and corrective action processes are efficient, operationally sound, and proactively managed. This role requires frequent collaboration with stakeholders at all levels of the organization to identify risks, resolve issues, and support a culture of compliance. Candidates must demonstrate strong communication, adaptability, and conflict resolution skills, as well as ability of lead others effectively. This is a telecommuter position and includes supervisory responsibilities. Competencies: Functional: Lead and oversee a team on execution of all aspects of regulatory and client audits, including: Pre-site deliverables Mock audits On-site logistics Written responses to audit findings and corrective action plans Interface with external clients and regulatory bodies to address inquiries, and support audit or examination activities. Coordinate across teams to document, monitor and ensure timely completion of corrective actions driving accountability and successful resolution of compliance issues. Collaborate closely with compliance leadership on audit execution and corrective action planning. Prepare and assist with monthly metrics reporting, including reporting to oversight committees and boards. Monitor team performance, provide regular feedback, and support continuous improvement initiatives. Proactively identify, address, and resolve compliance issues in partnership with business stakeholders. Research, interpret, and communicate applicable regulatory and contractual requirements. Foster a positive and engaged team culture. Perform additional duties assigned by leadership. Core: Ability to guide, coach, and develop team members while setting clear expectations. Ability to develop effective reports to synthesize compliance information to different audiences. Ability to manage time effectively and efficiently Skilled in analyzing data, trends, and findings to draw accurate conclusions and support decision-making Ability to work independently and with minimal direction Demonstrated project management skills Clear, concise and professional written and verbal communication skills Ability to demonstrate critical thinking skills Behavioral: Collegiality: building strong relationships on company-wide, approachable, and helpful, ability to mentor and support team growth. Initiative: readiness to lead or take action to achieve goals. Communicative: ability to relay issues, concepts, and ideas to others easily orally and in writing. Member-focused: going above and beyond to make our members feel seen, valued, and appreciated. Detail-oriented and thorough: managing and completing details of assignments without too much oversight. Flexible and responsive: managing new demands, changes, and situations. Critical Thinking: effectively troubleshoot complex issues, problem solve and multi-task. Integrity & responsibility: acting with a clear sense of ownership for actions and decisions and to keep information confidential when required. Collaborative: ability to represent your own interests while being fair to those representing other or competing ideas in search of a workable solution for all parties. Minimum Qualifications: Bachelor's degree in business, healthcare, or related area of study, or equivalent education and work experience 5+ years of experience in compliance, privacy and/or regulatory affairs or with supporting audits in a highly regulated industry; preferably a government, health care or managed care environment 3-5 years' experience with Medicare, Medicaid, or Commercial health plan regulations Proficiency in MS Word, Excel, and PowerPoint, including the ability to create and format professional documents, develop complex spreadsheets with formulas and pivot tables Strong attention to detail and ability to manage multiple priorities Demonstrated ability to work independently and meet deadlines As this role is a remote role, you are required to maintain internet service that allows you to complete your essential job duties without issue. Rates of 50 Mbps download and 10 Mbps upload while hardwired and not on a VPN are sufficient. Ability to travel as necessary (up to 25%) Preferred Qualifications: 3+ years of experience in supervisory or management level with direct reports Working knowledge of managed care and dental/vision benefit plans At Avēsis, we strive to design equitable, and competitive compensation programs. Base pay within the range is ultimately determined by a candidate's skills, expertise, or experience. In the United States, we have three geographic pay zones. For this role, our current pay ranges for new hires in each zone are: Zone A: $74,260.00-$123,760.00 Zone B: $80,940.00-$134,900.00 Zone C: $87,150.00-$145,250.00 FLSA Status: Salary/Exempt This role may also be eligible for benefits, bonuses, and commission. Please visit Avesis Pay Zones for more information on which locations are included in each of our geographic pay zones. However, please confirm the zone for your specific location with your recruiter. We Offer Meaningful and challenging work opportunities to accelerate innovation in a secure and compliant way. Competitive compensation package. Excellent medical, dental, supplemental health, life and vision coverage for you and your dependents with no wait period. Life and disability insurance. A great 401(k) with company match. Tuition assistance, paid parental leave and backup family care. Dynamic, modern work environments that promote collaboration and creativity to develop and empower talent. Flexible time off, dress code, and work location policies to balance your work and life in the ways that suit you best. Employee Resource Groups that advocate for inclusion and diversity in all that we do. Social responsibility in all aspects of our work. We volunteer within our local communities, create educational alliances with colleges, drive a variety of initiatives in sustainability. How To Stay Safe Avēsis is aware of fraudulent activity by individuals falsely representing themselves as Avēsis recruiters. In some instances, these individuals may even contact applicants with a job offer letter, ask applicants to make purchases (i.e., a laptop or gift cards) from a designated vendor, have applicants fill out W-2 forms, or ask that applicants ship or send packages of goods to the company. Avēsis would never make such requests to applicants at any time throughout our job application process. We also would never ask applicants for personal information, such as passport numbers, bank account numbers, or social security numbers, during our process. Our recruitment process takes place by phone and via trusted business communication platform (i.e., Zoom, Webex, Microsoft Teams, etc.). Any emails from Avēsis recruiters will come from a verified email address ending in @ Avēsiscom. We urge all applicants to exercise caution. If something feels off about your interactions, we encourage you to suspend or cease communications. If you are unsure of the legitimacy of a communication you have received, please reach out to ********************. To learn more about protecting yourself from fraudulent activity, please refer to this article link (************************************************** If you believe you were a victim of fraudulent activity, please contact your local authorities or file a complaint (Link: ******************************* with the Federal Trade Commission. Avēsis is not responsible for any claims, losses, damages, or expenses resulting from unaffiliated individuals of the company or their fraudulent activity. Equal Employment Opportunity At Avēsis, We See You. We celebrate differences and are building a culture of inclusivity and diversity. We are proud to be an Equal Employment Opportunity employer that considers all qualified applicants and does not discriminate against any person based on ancestry, age, citizenship, color, creed, disability, familial status, gender, gender expression, gender identity, marital status, military or veteran status, national origin, race, religion, sexual orientation, or any other characteristic. At Avēsis, we believe that, to operate at the peak of excellence, our workforce needs to represent a rich mixture of diverse people, all focused on providing a world-class experience for our clients. We focus on recruiting, training and retaining those individuals that share similar goals. Come Dare to be Different at Avēsis, where We See You!

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. **Qualifications:** **Required** + Bachelor's degree in science required; Master's degree in science preferred + 5+ (e.g. 5-7) years in a discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred. + Strong scientific knowledge and regulatory experience applicable to the role. Solid basis in scientific approach, an ability to deal with technical information from a variety of disciplines + Good technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and including knowledge of regulatory requirements and ICH guidance. + Proven track record of interaction with regulatory authorities. + Very good interpersonal, verbal and written communication skills with an ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders. + Strong analytical and problem-solving skills + Good negotiation skills **Preferred:** + Experience participating in a multi-national environment + Proven track record in submissions and achieving approvals. + For roles within a GRA development TA, a track record in development and a foundation for global responsibilities in a development project including communication, alignment and success in association with regulatory strategies is preferred. **Salary Range** $122,500 - $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory Strategy- Oncology Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

The Trade Compliance Manager will support key risk areas of the North American Trade Compliance team, ensuring adherence to import and export regulations while improving cash flow, increasing supply chain speed, and reducing risk. This individual contributor role is part of a comprehensive global trade compliance program that adapts to the changing regulatory environment and business requirements. This is a remote position for candidates available to work east coast hours. EXPECTATIONS Ensure compliance with U.S. import regulations with CBP and Other Government Agencies Manage duty remediation strategy for IEEPA, Section 301/232 and AD/CVD tariffs Develop FTA/USMCA policy and procedures, including delivering training where needed Prepare and review import documentation for accuracy and regulatory compliance Implement trade compliance related software related to free trade agreement qualification & audit Monitor trade laws and regulations, incorporating changes and providing leadership updates Conduct audits and risk assessments to ensure compliance and identify gaps and corrective actions Provide trade compliance guidance and support to cross-functional teams ESSENTIALS Bachelor's degree in international business or a related field LCB or CCS certification strongly preferred 8+ years of experience in trade compliance, customs, focused on U.S. regulations In-depth understanding of U.S. and international trade laws (HTS, County of Origin, FTA/USMCA, valuation, etc) Experience supporting audits, investigations, and regulatory inquiries Strong analytical skills with high attention to detail Excellent communication and people skills Ability to work in fast paced environment as an individual contributor Proficiency with trade compliance software and tools Experience working with a multinational company with global trade teams

As the global leader in high-speed connectivity, Ciena is committed to a people-first approach. Our teams enjoy a culture focused on prioritizing a flexible work environment that empowers individual growth, well-being, and belonging. We're a technology company that leads with our humanity-driving our business priorities alongside meaningful social, community, and societal impact. We are seeking a Director to lead our tax provision and compliance team. This role involves leading the daily execution and ongoing development of both U.S. and foreign income tax provision and compliance processes. This position reports directly to the Senior Director, Global Tax and will collaborate closely with key internal partners from Tax, Controllership, Legal, Internal Audit, FP&A, and Treasury, to optimize tax structures, manage effective tax rates, optimize cash tax flows, ensure compliance with tax laws and filing requirements, minimize risks and tax exposures. Responsibilities: Own the preparation and review of the quarterly and annual tax provision in compliance with ASC 740, FIN 18, and other related standards. Manage all aspects of global income tax reporting, including deferred tax assets/liabilities, valuation allowances, uncertain tax positions, and effective tax rate calculations. Support documentation and tax research for income tax strategies, policies and positions Support forecast modeling with respect to future effective tax rates and cash taxes in collaboration with FP&A Oversee the preparation and filing of federal and state tax income tax returns. Ensure timely and accurate return-to-provision reconciliation adjustments. Partner with key teams to prepare tax disclosures for SEC filings (e.g., 10-K, 10-Q) and other financial statements. Monitor and analyze legislative and regulatory changes, assessing their impact on the organization's tax positions and financial statements. Lead process optimization initiatives, including evaluating and implementing tax technology tools for greater efficiency and accuracy. Maintain SOX-compliant internal controls related to tax reporting and compliance. Provide technical leadership and mentorship to tax staff, managing performance and fostering professional development. Represent the tax team in discussions with external auditors, advisors, and relevant authorities as needed. Manage, mentor, and develop a team of tax professionals to maximize their performance and career growth, fostering a culture of continuous learning and collaboration. Support the business on ad-hoc tax inquiries and various non-income tax analyses and filings on an as-needed basis Manage and oversee income tax audits and inquiries, working closely with external advisors and internal stakeholders to address and resolve issues. About You Experience: 12+ years of progressive tax experience, with expertise in ASC 740, SBC, Section 174, R&D tax credits and tax compliance. Background in public accounting (Big 4 preferred) and/or corporate tax in a multinational public company. Strong understanding of global tax compliance and reporting issues. Education & Certification: Bachelor's degree in Accounting, Finance, or related field required; CPA and/or MST (Master's in Taxation) strongly preferred. Skills: Demonstrated ability to lead high-performing teams and manage a large-scale tax provision and compliance function. Expert-level knowledge of U.S. GAAP, international tax principles, and related reporting requirements. Proven track record of process improvement, including the use of tax technology to drive efficiencies. Ability to work under tight deadlines in a fast-paced, ever-changing environment. Excellent analytical thinking, communication, and relationship-building skills. Demonstrated ability of cultivating talent, fostering both technical excellence and interpersonal growth. Positive attitude, enthusiasm, and team building skills Pay Range: USA: $173,600 - $ 250,400 Pay ranges at Ciena are designed to accommodate variations in knowledge, skills, experience, market conditions, and locations, reflecting our diverse products, industries, and lines of business. Please note that the pay range information provided in this posting pertains specifically to the primary location, which is the top location listed in case multiple locations are available. Non-Sales employees may be eligible for a discretionary incentive bonus, while Sales employees may be eligible for a sales commission. In addition to competitive compensation, Ciena offers a comprehensive benefits package, including medical, dental, and vision plans, participation in 401(K) (USA) & DCPP (Canada) with company matching, Employee Stock Purchase Program (ESPP), Employee Assistance Program (EAP), company-paid holidays, paid sick leave, and vacation time. We also comply with all applicable laws regarding Paid Family Leave and other leaves of absence. Not ready to apply? Join our Talent Community to get relevant job alerts straight to your inbox. At Ciena, we are committed to building and fostering an environment in which our employees feel respected, valued, and heard. Ciena values the diversity of its workforce and respects its employees as individuals. We do not tolerate any form of discrimination. Ciena is an Equal Opportunity Employer, including disability and protected veteran status. If contacted in relation to a job opportunity, please advise Ciena of any accommodation measures you may require.

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.

MODE Global is the 5th largest truckload broker and largest non-asset intermodal provider in North America. With over 200 agents/offices distributed from coast to coast, MODE Global operates under a family of businesses and brands, delivering as a premier full-service solutions provider to the logistics industry. Job Title: Carrier Compliance Manager Job Summary: The Carrier Compliance Manager plays a crucial role in ensuring that carriers (transportation companies) comply with all relevant regulations and standards governing their operations. This role involves developing and implementing compliance strategies, monitoring carrier activities, and maintaining up-to-date knowledge of regulatory changes. The Carrier Compliance Manager collaborates closely with internal teams and external stakeholders to uphold compliance and mitigate risks associated with transportation operations. Responsibilities: Develop and implement compliance policies and procedures for carriers in accordance with local, state, and federal regulations. Conduct regular audits and inspections of carrier operations to ensure adherence to compliance standards. Provide guidance and training to carriers on compliance requirements and best practices. Monitor carrier performance metrics to identify areas for improvement and compliance gaps. Investigate and address compliance violations, taking corrective actions as necessary. Stay informed about changes in transportation regulations and industry trends and communicate updates to relevant stakeholders. Collaborate with cross-functional teams, including operations, legal, and procurement, to address compliance-related issues and implement solutions. Maintain accurate records and documentation related to carrier compliance activities. Develop and maintain relationships with regulatory agencies and industry associations to stay abreast of regulatory developments and participate in industry initiatives. Analyze data and trends to identify potential compliance risks and opportunities for process improvement. Work with outside agencies, i.e. RMIS, SAFER, DOT, DOI to ensure proper regulatory compliance for carriers. Take part in the hiring/training of new hires or re-training of internal staff. Create SOPs, guidelines for staff to ensure proper vetting practices. Working with Corporate Ops to prevent and maintain logs for Bad Actors and Double Brokering matters. Participate in projects and Senior Leadership discussions regarding people and process management. Have biweekly/monthly meetings with Compliance Leaders to ensure process management and share ideas on progression of Compliance management. Qualifications • 10 years in business administration, logistics, supply chain management, or a related field. • Previous experience in transportation, logistics, or regulatory compliance preferred. • Strong understanding of transportation regulations and compliance requirements. • Excellent analytical skills and attention to detail. • Effective communication and interpersonal skills. • Ability to work independently and collaboratively in a fast-paced environment. • Proficiency in Microsoft Office Suite and other relevant software applications. • Certification in transportation compliance or related field (e.g., Certified Transportation Professional) is a plus. Expectations: • The Carrier Compliance Manager is expected to demonstrate a high level of integrity and professionalism in carrying out their responsibilities. • They should possess strong leadership skills and the ability to influence and drive compliance initiatives across the organization and with external partners. • Additionally, the successful candidate should be proactive in identifying compliance risks and implementing effective solutions to mitigate them. • The Carrier Compliance Manager should stay current with regulatory changes and industry best practices to ensure that the organization remains in compliance and operates efficiently. • This role requires a commitment to continuous improvement and a willingness to adapt to evolving regulatory requirements and business needs. Why MODE? MODE Global is the 5th largest truckload broker and largest non-asset intermodal provider in North America. With over 200 agents/offices distributed from coast to coast, MODE Global operates under a family of businesses and brands, delivering as a premier full-service solutions provider to the logistics industry. At MODE, we're dedicated to providing our employees with a working environment where they can flourish professionally and personally. You can expect an inclusive and supportive workplace where people help each other succeed. Our benefits package is exceptional, including medical, dental, and vision with flexible time off policies. We believe in the future of our employees, so we offer a generous match to your 401k plan. With locations all across the United States, you can join us in providing transportation and logistics solutions to our customers.

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

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 How Toast Uses AI in its Hiring Process Throughout the hiring process, our goal is to get to know you. We use AI tools to support our recruiters and interviewers with tasks like note-taking, summarization, and documentation of interviews to ensure they can be fully focused on your conversation. All hiring decisions are made by people. 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.

Recruitment Fraud Alert We've learned that scammers are impersonating Commvault team members-including HR and leadership-via email or text. These bad actors may conduct fake interviews and ask for personal information, such as your social security number. What to know: Commvault does not conduct interviews by email or text. We will never ask you to submit sensitive documents (including banking information, SSN, etc) before your first day. If you suspect a recruiting scam, please contact us at ****************************** About Commvault Commvault (NASDAQ: CVLT) is the gold standard in cyber resilience. The company empowers customers to uncover, take action, and rapidly recover from cyberattacks - keeping data safe and businesses resilient. The company's unique AI-powered platform combines best-in-class data protection, exceptional data security, advanced data intelligence, and lightning-fast recovery across any workload or cloud at the lowest TCO. For over 25 years, more than 100,000 organizations and a vast partner ecosystem have relied on Commvault to reduce risks, improve governance, and do more with data. The Opportunity... Commvault is seeking a Regulatory Compliance Associate with a focus on Privacy and AI Governance to support the operational execution and continuous improvement of our global compliance programs. This role is ideal for a compliance professional with strong hands-on experience who can independently manage workflows, partner cross-functionally, and help mature privacy and AI governance operations at scale. What you'll do... Own and execute key operational workflows across privacy and AI governance, ensuring consistency, timeliness, and audit readiness. Independently manage data subject rights requests (DSRs), including intake, coordination, tracking, and response support. Support and coordinate privacy impact assessments (PIAs/DPIAs) and AI risk assessments, including documentation and follow-ups. Operationalize global privacy and AI regulatory requirements (e.g., GDPR, CCPA, EU AI Act) into repeatable processes and guidance. Maintain and continuously improve Privacy & AI compliance documentation, including policies, procedures, playbooks, and internal guidance. Support partnerships with product, engineering, security, and legal teams to embed privacy-by-design and responsible AI-by-design practices. Manage Privacy & AI compliance trackers, repositories, and tooling to ensure visibility, accountability, and reporting accuracy. Support third-party, vendor privacy, and AI compliance assessments, including documentation review and remediation tracking. Assist with regulatory inquiries, audits, and internal reviews by coordinating input and preparing supporting materials. Develop and deliver training content, enablement materials, and communications to support privacy and AI governance awareness. Track operational metrics and identify process gaps or opportunities for program improvement. Support additional initiatives across privacy, AI governance, and broader regulatory compliance as needed. Who you are... 1-3 years of professional experience in regulatory compliance, privacy operations, legal operations, or governance roles. Strong working knowledge of global privacy regulations (e.g., GDPR, CCPA) with practical exposure to AI governance or emerging technology risk. Demonstrated experience running compliance workflows end-to-end with minimal supervision. Operational mindset with the ability to translate regulatory requirements into scalable processes. Strong organizational and project management skills with excellent attention to detail. Excellent written and verbal communication skills, including drafting operational documentation and stakeholder guidance. Comfort working cross-functionally with technical and non-technical teams. Experience with compliance tools, trackers, or regulatory management systems is a plus. Relevant certifications (e.g., CIPP/E, CIPP/US, CIPM) are preferred but not required. You'll love working here because... Continuous professional development, product training, and career pathing An inclusive company culture, opportunity to join our Employee Resource Groups (ERGs) Generous benefits supporting your health, financial security, and work-life balance Employee stock purchase plan (ESPP) Ready to #makeyourmark at Commvault? Apply now! LI-PK1 LI-Remote Thank you for your interest in Commvault. Reflected below is the minimum and maximum base salary range for this role. At Commvault we use broad salary ranges in our job postings to reflect the diverse levels of expertise and experience among our candidates and is not reflective of the total compensation and benefits package. The specific salary offered will be determined based on your unique qualifications, including your relevant experience, skills, and the value you bring to the role. While the range provides a general idea of the compensation, it is important to note that placements within the range are not automatic and will be carefully considered to ensure a fair and competitive offer. We are committed to rewarding talent and experience. Pay Range$54,400-$120,750 USD Commvault is an equal opportunity workplace and is an affirmative action employer. We are always committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status and we will not discriminate against on the basis of such characteristics or any other status protected by the laws or regulations in the locations where we work. Commvault's goal is to make interviewing inclusive and accessible to all candidates and employees. If you have a disability or special need that requires accommodation to participate in the interview process or apply for a position at Commvault, please email accommodations@commvault.com For any inquiries not related to an accommodation please reach out to ******************************. Commvault's Privacy Policy