Regulatory Affairs Director remote jobs - 170 jobs

A leading nonprofit organization in California is seeking a Payroll Director to manage payroll operations for 1,000 employees, ensuring compliance with regulations and leading audits. The ideal candidate will have significant experience in a high-volume payroll environment, and knowledge of California payroll regulations. This role offers a competitive salary and a flexible hybrid working schedule. #J-18808-Ljbffr

A leading health organization seeks a Director of Home Health Risk Management. This role involves analyzing risk sources, developing compliance strategies, and leading a team to enhance efficiency in Home Health operations. Candidates should have a Bachelor's degree, significant management experience, and an understanding of regulatory compliance. Join us to impact the health sector positively while working in a collaborative environment. Competitive salary and benefits are offered, and occasional travel may be required. #J-18808-Ljbffr

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 250 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 DIRECTOR, GOVERNMENT AFFAIRS The Director, Government Affairs will be responsible to advocate and advance EEI's policy priorities with Congress, the Administration, and other stakeholder groups on all issues relating to energy and electric power sector including the Federal Power Act, grid security, transmission, electrification, general supply chain issues; energy storage, energy efficiency, federal agency energy issues, and various environmental regulations. Other important responsibilities of the Director, Government Affairs: Develop & coordinate comprehensive strategies to achieve the industry's goals on the relevant energy issues. This includes direct advocacy, communications, coalitions development, and third-party advocacy with various energy and businesses. Coordinate and work closely with all of the various policy teams within EEI including the Legal, Environment, Security & Preparedness, Communications, and External Affairs departments to develop education materials on legislation & industry issues to be used by EEI staff, member companies, and external stakeholders; assist in drafting legislation, amendments and report language; draft letters to Congress and the Administration expressing EEI's position on relevant issues; work with EEI staff in drafting testimony to congressional committees on behalf of EEI; assist in briefing EEI hearing witnesses. Participate and represent EEI in various conferences and forums to support EEI member companies and advance various industry issues. Ensure that our key priorities are shared with Senators, Members of Congress, Congressional staff, and Administration officials and that those priorities are reflected in federal legislation and regulations. REQUIRED QUALIFICATIONS: Candidates should have a bachelor s degree in political science or public policy or equivalent work experience. In addition: 10-12 years of experience in the federal legislative and political process and an ability to manage and coordinate legislative activities. Established relationships with Members of Congress, Congressional staff, Administration and various outside stakeholders and third-party groups. Strong interpersonal and communication skills, with the ability to effectively engage diverse audiences, including government officials, EEI members, and senior leadership. Need to demonstrate strong initiative and leadership skills. Exceptional organizational skills and the ability to manage multiple priorities effectively. Ability to work effectively with a broad range of staff and external stakeholders. Travel is required to various EEI meetings and meetings with external stakeholders. HOW TO APPLY Interested applicants should apply online through EEI s career site. EEI uses Clear Company as our applicant tracking system. An application is considered when all required fields are completed. COMPENSATION The salary range for this role is $130,000 $175,000. 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 annual bonus. 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.

Job Description At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients. Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. This is a Remote position. Responsibilities include: Act as the primary Regulatory expert within an assigned clients Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned products lifecycle. Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. Qualifications for this position include: At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. Ability to work independently in a remote role with minimal oversight. Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. Bachelors degree (advanced degree in a science discipline preferred) As a part of our full-time team, you are eligible for our Comprehensive Benefits including: Medical, Dental and Vision Insurance Disability Insurance and Life Insurance 401(k) program with company match A balanced approach to work-life that offers a generous PTO program and Holidays. This is a remote position.

SummaryThe Global Head, Regulatory Affairs - Labeling sets the enterprise labeling vision and delivers the strategic labeling agenda across PDx: from target product profile (TPP) and target product labeling (TPL) through Company Core Data Sheet (CCDS) stewardship and global implementation. This leader ensures that labeling is a core lever for product positioning and market access, translating clinical and CMC evidence into precise, defensible labeling language that differentiates our portfolio and enables compliant promotion and reimbursement. The role owns the end to end global labeling framework, governance, metrics, and systems, and leads high stakes agency negotiations to defend labeling and secure optimal indications and claims. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job Description Key Responsibilities: Strategic Labeling & Product Positioning Lead the global labeling strategy for all PDx products (development and marketed), aligning with TPP/TPL and commercial strategies to enable optimal indications, claims, and competitive positioning. Provide early, proactive feedback on clinical and CMC plans (Phase I-III and LCM) to shape endpoints, analyses, and evidence packages that unlock the best label and access outcomes. Chair the Global Labeling Committee and Labeling Working Groups, driving crisp decisions, risk/benefit trade‑offs, and cross‑functional alignment. CCDS Ownership & Global Implementation Own CCDS creation, maintenance, and change control; ensure timely, consistent roll‑out into US, EU, China, Japan and other markets, with documented exceptions and transparent rationale. Establish and track labeling KPIs (e.g., cycle times, first‑pass acceptance, variation close‑out, deviation rate) and drive continuous improvement across processes, templates, and training. Agency Engagement & Negotiation Serve as the principal labeling negotiator with FDA, EMA/NCAs, NMPA (China), PMDA (Japan) and other authorities; lead labeling‑focused meetings and written interactions to defend indication, population, claims, dosing, warnings, and promo‑relevant language. Anticipate and mitigate labeling risks that lead to CRLs, REMS/PMR/PMC obligations, or restrictive language; escalate and resolve issues decisively. Cross‑Functional Influence & Commercial Enablement Partner with Market Access, Commercial, Medical, and Legal/Promo Review to ensure label‑to‑launch readiness and compliant promotional scope aligned to positioning and payer needs. Translate complex regulatory concepts into clear executive narratives; influence senior stakeholders on evidence/label trade‑offs and go‑to‑market implications. Operating Model, Systems & Compliance Build and evolve the Global Labeling Center of Excellence, including governance, end‑to‑end processes, metrics, inspection readiness, and systems (e.g., Veeva RIM, ePI). Ensure audit/inspection readiness and robust documentation across labeling decisions, deviations, and exceptions. Ad Promo Oversight Work with the Global Head RA, Ad Promo to provide the overarching leadership, alignment, and governance needed to ensure consistency between labeling, promotional claims, product positioning, market access needs, and global regulatory expectations. Qualifications: Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical companies, with a record of successful label negotiations and defense at FDA/EMA/NMPA/PMDA. Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial to shape development and lifecycle plans toward best‑possible labeling and access. Deep expertise in CCDS, core/product information, and global/local labeling execution (US/EU at minimum). Exceptional negotiation and stakeholder management skills, internally and externally; proven ability to craft precise, defensible labeling language from clinical data. Strong people leadership: building high‑performing teams, setting standards, and coaching labeling professionals and cross‑functional contributors. Desired Characteristics: Hands‑on experience with Veeva RIM and labeling systems; understanding of ePI evolution. Prior stewardship of a Global Labeling Committee/Working Group with measurable KPI improvement. Advanced degree in life sciences or pharmacy; Market Access literacy to connect label language to reimbursement and promo scope. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $172,800.00-$259,200.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: February 16, 2026

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline. We are seeking a highly motivated Director, Regulatory Affairs, reporting to the VP of Regulatory Affairs, who will lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration for assigned programs. The Director will represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late-stage development programs. Responsibilities: Independently serve as the regulatory representative on cross-functional teams. Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed. Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans. Independently lead the central messaging, preparation, and submission of high-quality, regulatory-complaint regulatory dossiers. Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams. Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements. Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines. Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable. Serve as the regulatory point of contact for interactions with FDA and other global health authorities. Critically review nonclinical and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives. Interact directly with regulatory agencies; manage agency interactions. Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations. May assist with due diligence to support business development opportunities. Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations. Qualifications: B.S./M.S. degree in a scientific discipline or related field. Minimum of 10 years of Pharmaceutical Regulatory Affairs experience; experience in neuropsychiatric indications preferred. Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required. Experience supporting development stage programs (Phase 1-3). Experience with IND/CTA and license applications. Experience with management of commercial product(s) highly desirable. Ability to work in a hybrid environment and with distributed teams; startup/small company experience preferred. Self-starter who can independently lead assigned projects. Experience in central nervous system disease research a plus. Strong analytical skills, problem solving ability, and presentation skills. Excellent communication and interpersonal skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds. 2026 Company benefits include: Medical, dental, vision, and life insurance 401(k) plan: Neumora matches 50% of an employee's eligible contribution, up to the first 6% of salary (up to 3% employer contribution) Company Equity (New Hire Awards, Annual Awards, ESPP) Annual paid time off: Accrued Vacation Days: 15 days per year Sick Days: 10 days per year Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability Discretionary year-end bonus The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range:$221,675 -$244,434 Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases. Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients. Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives. Key Responsibilities Develop and implement global CMC and device regulatory strategies for assigned program(s) Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions) Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans Identify regulatory risks associated with product development and propose mitigation strategies Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes Archive and maintain regulatory submissions and correspondences in Apogee's regulatory information management system Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth Ideal Candidate Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred Proven track record of leading cross-functional submission teams and successful regulatory submissions Strong knowledge of global regulatory requirements (FDA, EMA, ICH) Excellent communication, leadership, and project management skills Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment Up to 15 - 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient, and Egoless The anticipated salary range for candidates for this role will be $220,000-$240,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here 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.

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director, Medical Affairs Governance will play a critical leadership role in ensuring robust governance, compliance, and operational excellence across all Medical Affairs functions, assets, and regions. This role will establish and oversee global governance frameworks, including Medical Review Committees (MRCs), SOPs, inspection readiness, and cross-functional medical governance initiatives. The ideal candidate will have deep expertise in global medical governance, compliance, and regulatory frameworks within the biotech/pharmaceutical industry. Key responsibilities include: Medical Governance & Compliance Leadership Develop and implement a comprehensive global Medical Governance framework to support strategic and operational excellence across Medical Affairs. Lead governance process for Medical Affairs, including facilitation and coordination of the Medical Project Review Group. Lead governance for all Medical Affairs functions, including medical information, medical education, scientific engagement, congress strategy, and publications. Partner with cross-functional teams (Legal, Compliance, Regulatory) to ensure adherence to industry standards, company policies, and regulatory requirements. Oversee the medical review responsibilities and process for Medical Legal Review committees, ensuring efficient and compliant medical review of materials, communications, and scientific content. Ensure medical activities align with corporate policies and external regulatory guidance, including FDA, EMA, PhRMA Code, ICH, GVP, and other relevant regulations. SOPs, Policies & Process Development Establish, maintain, and optimize global Medical Affairs Standard Operating Procedures (SOPs), Work Instructions, and best practices to drive consistency and compliance. Conduct periodic reviews of policies and ensure Medical Affairs teams are trained on key processes. Partner with Compliance on SOP initiatives. Drive continuous improvement efforts to streamline governance frameworks and enhance efficiency within Medical Affairs operations. Inspection Readiness & Audit Support Lead inspection readiness efforts across Medical Affairs, ensuring processes, documentation, and governance frameworks meet regulatory expectations. Act as a point of contact for regulatory inspections and internal audits, providing oversight and guidance on Medical Affairs-related compliance activities. Collaborate with QA and Compliance to identify risks, implement corrective and preventive actions (CAPAs), and maintain audit readiness. Cross-Functional Collaboration & Global Medical Governance Work across therapeutic areas, geographies, and functions to ensure seamless integration of governance processes within the global Medical Affairs organization. Provide strategic guidance to Medical Affairs leadership on governance best practices and risk mitigation strategies. Act as the key liaison between Medical Affairs, Compliance, Legal, and other internal stakeholders to align governance initiatives across the organization. Required Skills, Experience and Education: Advanced scientific or medical degree (PhD, PharmD, MD) preferred; MS or equivalent experience in biomedical sciences or related field considered. 10+ years of experience in Medical Affairs or related functions within the biotechnology, pharmaceutical, or healthcare industry. Strong background in Medical Governance, Compliance, Regulatory Affairs, or Medical Operations. Experience working in global biotech/pharmaceutical environments, supporting multiple regions and therapeutic areas. Deep knowledge of global regulatory requirements for Medical Affairs, including FDA, EMA, ICH, GVP, and industry best practices. Proven experience developing SOPs, policies, and governance frameworks to support medical organizations. Strong track record in inspection readiness, audits, and compliance oversight for Medical Affairs functions. Ability to navigate complex regulatory and legal environments and advise teams on governance best practices. Experience leading Medical Review Committees (MRCs) or similar governance structures. Strong interpersonal, communication, and leadership skills with the ability to influence cross-functional stakeholders. Preferred Skills: Prior experience in oncology, precision medicine, or targeted therapies. Expertise in digital platforms for compliance tracking, document management, and governance reporting. #LI-Remote #LI-YG1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range$211,000-$264,000 USD

Site Name: UK - Hertfordshire - Ware RD, Belgium-Wavre, GSK HQ, Italy - Siena, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. We value clear decision makers who build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications. * Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders. * Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply. * May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. * Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK. * Identify regulatory risks and propose clear mitigation plans to senior leadership. * Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions. * Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs. * Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability. * Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines. Problem Solving skills * Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management. * Formulates novel approaches and influences people, systems, and processes. * Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies. * Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems. * Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work. Qualifications Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals * Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline. * Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements. Preferred Qualification If you have the following characteristics, it would be a plus * Advanced degree (MSc or PhD) in a relevant scientific discipline. * Experience leading CMC regulatory teams or line management responsibility. * Experience with lifecycle management and post-approval regulatory activities. * Experience with cell and gene therapies, therapeutic proteins or other complex biologics. * Demonstrated success leading major inspections or regulatory interactions. * Practical experience with global regulatory frameworks and agency engagement. * Experience with mentoring junior colleagues * Proven track record preparing or contributing to global CMC submissions. * Experience engaging with cross-functional teams across R&D, supply and quality. * Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities. * Ability to manage multiple projects, set priorities and meet timelines. Working pattern and location This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (UP or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on-site and remote working. Specific on-site days will be agreed with your manager to support team collaboration and stakeholder engagement. How to apply We would welcome your application. Please include a short cover letter or summary that explains how your experience fits this role and why you are interested. We are committed to inclusion and will consider reasonable adjustments to support you during the application process. Apply today and help us move science forward to make a real difference for patients. * If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $173,250 to $288,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ********************************* where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Director of Regulatory Affairs, Advertising & Promotion will own and drive regulatory leadership and oversight for advertising, promotional, and non-promotional activities supporting cell therapy, biologics, combination products and medical devices. This individual will be responsible for ensuring that all promotional materials and communications are scientifically accurate, compliant with FDA and other global regulatory standards, and aligned with company objectives. The role requires strong expertise in regulatory requirements for advanced therapies and combination products, the ability to chair and guide promotional review processes, and proven leadership in cross-functional and regulatory authority interactions. Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. Position Scope: * Enable the business by providing regulatory guidance and oversight for U.S. and global advertising and promotional activities supporting cell therapy, biologics, combination products and medical devices. * Leverage strong written/verbal communication skills to review and approve all promotional, non-promotional, and scientific materials to ensure accuracy, fair balance, and compliance with applicable regulations. * Partner and build strong relationships cross-functionally with Medical, Legal, Quality, and Commercial to ensure promotional content is scientifically rigorous and compliant. * Chair high-volume Medical, Legal, Regulatory (MLR) meetings for Vericel's brands sharing the regulatory perspective with the goal of enabling business and mitigating risk. * Serve as primary contact and SME with FDA OPDP/APLB and other health authorities. * Maintain deep expertise in FDA regulations, guidance documents, and enforcement actions pertaining to advertising and promotion; monitor regulatory developments and communicate changes and implications to internal stakeholders. * Ensure the promotional review process is efficient, consistent, and aligned with regulatory expectations, with the goal of supporting business agility while minimizing compliance risk. * Develop, implement, and continuously improve processes, SOPs, and best practices for the review and approval of advertising and promotional materials, including integrating new AI technologies. * Provide training and education to internal teams on requirements for prescription product promotion. * Partner with and advise product development and brand teams on advertising and promotional considerations during product development, launch planning, and lifecycle management. * Participate in or lead regulatory project team and labeling meetings, providing strategic input on promotional implications of proposed labeling, new claims, and campaign concepts. Qualifications: * Bachelor of Science in a scientific discipline; Master's degree preferred. * 10+ years direct Regulatory Affairs experience with at least 5+ years of experience in regulatory review of promotional materials for prescription drug or biologic products. * Proven track record in managing promotion review committees (e.g. PRC) or other regulatory governance forums. * Deep knowledge of FDA / OPDP / APLB regulations; global experience with promotional guidance and enforcement trends in advertising and promotion preferred. * Experience in negotiations and/or formal interactions with regulatory authorities (OPDP/APLB or equivalent) preferred. * Demonstrated ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Quality) and drive alignment under regulatory constraints. * Strong team player that has a customer service approach and is solution oriented. * Attention to detail, strong written and verbal communication skills and the ability to work individually, within a multidisciplinary team. * Experience authoring and implementing SOPs, review processes, training materials for promotional compliance. * Proven success in managing large, complex, time-sensitive projects in a regulated environment. Why Vericel? * Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. * Career Growth: Be a part of a growing organization with opportunities to expand your impact. * Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $188,000 to $235,000 annually. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Country: United States of America Hybrid U.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance Security Clearance: DoD Clearance: Secret RTX is an aerospace and defense company that provides advanced systems and services for commercial, military and government customers worldwide. It comprises four industry-leading businesses - Collins Aerospace Systems, Pratt & Whitney, Raytheon Intelligence & Space and Raytheon Missiles & Defense. Its 195,000 employees enable the company to operate at the edge of known science as they imagine and deliver solutions that push the boundaries in quantum physics, electric propulsion, directed energy, hypersonics, avionics and cybersecurity. The company, formed in 2020 through the combination of Raytheon Company and the United Technologies Corporation aerospace businesses, is headquartered in Arlington, VA. The following position is to join our RTX Enterprise Services team: Role Overview: We are seeking a highly skilled, experienced, innovation-oriented and results-driven Director of Digital Strategic Regulatory Services (SRS) across the organization. This role is critical in ensuring the security, integrity, and resilience of our digital assets and information systems. The Director of SRS will be responsible for identifying and developing the implementation strategy for regulatory requirements across RTX (Domestic and International) to support the company's strategic objectives and operational effectiveness through delivery of efficient and effective compliance services. The role will require a deep understanding of the regulatory landscape in aerospace and defense, the ability to lead through transformation, and successful partnership with key Enterprise functions. This role will evolve and lead an SRS program that is continuously monitoring and identifying new regulatory requirements and ensuring RTX is in the best position to comply. The role requires and active Secret Clearance is order to be considered. What You Will Do: Define and implement a comprehensive global regulatory strategy that aligns with the company's strategic goals. Ensures RTX global sites are compliant with digital policies, contractual requirements, and local regulations. Strong understanding of global digital controls, risk management frameworks, standards, and best practices (e.g., Part-IS, ISO, NIS2, NIST, CMMC, GDPR, CIS, SCF). Oversees the readiness of all unclassified Defense and Commercial systems for broad based assessment and certification including NIS2, Part-IS, ISO27001, AUS DISP, UK Cyber Essential/+, and CMMC, etc.. Inform, adopt and implement an operational strategy that leverages innovation and incorporates a Unified Controls Framework (UCF) across regulatory requirements to enable a test once use many approach to streamline assessments. Define, implement, operate and report on key performance indicators (KPIs) and key risk indicators (KRIs) metrics related to SRS. Lead the identification, assessment, prioritization and reporting of digital controls non-compliance risks across external assessments such as Part-IS, CMMC, DIBCAC, ISO, etc.. Lead and mentor a team of digital regulatory & controls professionals through transformation, fostering a culture of continuous improvement and innovation while inspiring to embrace RTX's core values Collaborate with cross-functional teams, including IT, cybersecurity, audit, legal, and compliance, to ensure a cohesive approach to regulatory & policy testing and assessment. Partner with other functions to drive the development and implementation of controls to safeguard digital assets and ensure compliance with industry standards and regulations. Serve as a subject matter expert on digital regulatory & policy matters, providing guidance and support to business units and stakeholders. Travel 25%. Qualifications You Must Have: A University Degree in Business, Science, Technology, Engineering or Mathematics and a minimum of 14 years of prior relevant experience, or an Advanced Degree in a related field and a minimum of 12 years of relevant experience. Minimum of 12 years of experience in digital controls, cybersecurity, capability maturity or a related discipline, with at least 5 years in a leadership role. Active and transferable U.S. government issued security clearance is required prior to start date. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance. Qualifications We Prefer: Preferably 5+ years of experience in a top-tier risk advisory or management consulting firm. Proven track record of successfully managing digital controls programs in large, complex organizations, preferably within the Aerospace and Defense industries. Ability to communicate with all levels of management verbally and written, facilitate effective meetings, build effective working relationships and partnerships, and strong interpersonal skills. Excellent analytical, problem-solving, and decision-making skills. Relevant certifications such as CISSP, CISM, CRISC, or similar are desirable. Highly proficient in Microsoft Office products with experience in preparing presentations and presenting to executive leadership Expert knowledge of national and international laws, regulations, policies, and ethics as they relate to cybersecurity (e.g., DFARS, FAR, ITAR, EAR, NIST 800-53, NIST 800-171) General knowledge of IT, Artificial Intelligence, and cybersecurity with experience in the following areas: incident response, business continuity/ disaster recovery, vulnerability management, application security, database security, identity & access management, OT security, cloud security, third-party & supply chain risk management What We Offer: Whether you're just starting out on your career journey or are an experienced professional, we offer a robust total rewards package with compensation; healthcare, wellness, retirement and work/life benefits; career development and recognition programs. Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance and child/adult backup care. Learn More & Apply Now! Work Location: Remote Please consider the following role type definition as you apply for this role: Remote: This position is currently designated as remote. However, the successful candidate will be required to work from one of the 50 U.S. states (excluding U.S. Territories). Employees who are working in Remote roles will work primarily offsite (from home). An employee may be expected to travel to the site location as needed. The salary range for this role is 176,000 USD - 352,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

Job Title: Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. You'll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject matter expert role wiht no direct reports, though there will be mentoring, training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process. Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business. Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy. Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork. Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities. Assists in ensuring product support relationships with FDA are established and maintained. Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. About You Earned Bachelor's degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data. Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions. Ability to generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans. Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally well. Deals with people in an honest and forthright manner representing information and data accurately. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Vice President, Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company's product development strategies and providing guidance to broader CMC functions. This individual will ensure all applicable CMC regulatory requirements are considered and appropriately incorporated into clinical and commercial product development plans. The incumbent will work collaboratively with senior leadership and key stakeholders to develop CMC regulatory objectives for one or more programs, lead the preparation and filing of regulatory CMC submissions, and manage the preparation for interactions with Health Authorities. This role may be fully remote or based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Travel to headquarters for meetings may be required at the discretion of management. Responsibilities (including, but not limited to): * Lead the development of CMC regulatory strategy for assigned clinical-stage programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle * Assess and communicate CMC regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction * Lead and facilitate the preparation for CMC-focused meetings with FDA, EMA, or national competent authorities, and participate in or lead the interactions with these agencies * Serve as the regulatory representative at internal CMC team meetings * Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and CMC regulatory submissions (e.g., original INDs, CMC amendments, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development * Provide regulatory review and input on core product development documentation (e.g., stability protocols and reports, method or process validation protocols and reports, specifications, technical assessments, etc.) * Lead and coordinate with appropriate team members and stakeholders to resolve outstanding CMC regulatory issues * Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success * Coordinate and conduct CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required * Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities * Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines * Bachelor's degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required * Minimum of 12 years of increasing responsibility in Regulatory Affairs CMC within the biopharmaceutical industry * Demonstrated recent successful Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and/or international countries * Proven experience in the review, authoring, and/or managing of components of regulatory submissions such as of INDs, CTAs, NDAs/BLAs or MAAs, and their maintenance * Demonstrated experience interacting with the US FDA, EU, EMA, and other regulatory agencies * Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities * Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies * Strong oral and written communication, time management, and team-oriented leadership skills are essential * Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors. * Proven mindset of proactive continuous improvement * Strong attention to detail * Ability to work in a fast paced-environment and to handle multiple tasks * Strong commitment to ethical standards * Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) * Ability to travel up to 10% * The salary range for this position is commensurate with experience Viridian offers a comprehensive benefits package including: * Competitive pay and stock options for all employees * Medical, dental, and vision coverage * Fertility and mental health programs * Short- and long-term disability coverage * Life, Travel and AD&D * 401(k) Company Match with immediate company vest * Employee Stock Purchase plan * Generous vacation plan and paid company holiday shutdowns * Various mental, financial, and proactive physical health programs covered by Viridian Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.

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

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.

**At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.** We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: _"What would I do if this patient were my mom?"_ That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. **Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.** **Position Summary** Manager - Regulatory Affairs is responsible for regulatory activities related to medical devices / in vitro diagnostic projects and applicable health authority submissions. This position will have a variety of responsibilities, including developing regulatory strategies, preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new policies and guidance from various regulatory agencies. **Job Responsibilities** + Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies. + Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change. + Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510(k)s, IDEs, PMAs, supplements, as well as international submissions like technical files for CE marketing and Clinical Performance Studies. + Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions. + Review and provide regulatory input on analytical and clinical study protocols. + Provide support, as needed, for Health Authority inspections, including but not limited to FDA inspections, Pre-Approval Inspections, BIMO or European Notified Body Inspections. + Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes. + Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities. + Support compliance activities associated with the Quality Management System to fulfil international and domestic policies and regulations. + Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies. **Required Qualifications** + Bachelor's degree in a science-related area of study. + 8+ years hands-on submission experience including the development and execution of regulatory strategies for medical device and/or IVD regulated products. + Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products. + Strong understanding of product development processes, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies. + Ability to work independently, taking ownership for the management of processes, projects, and timelines. + Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project. + Effective time management & project planning skills. **Preferred Qualifications** + Master's degree in a science-related area of study. + Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, software components of IVD medical devices, and NGS. + Experience leading and/or supporting US FDA medical device submissions. + Ability to mentor and lead others through challenging circumstances. **Physical Demands** + Employee may be required to lift routine office supplies and use standard office equipment. + Ability to sit/stand for extended periods of time while using a computer. **Training** + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + This position requires periodic travel and some evenings, weekends and/or holidays. + Job may require after-hours response or some work over the weekends/holidays to address emergency health authority submission related issues. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.

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

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

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.