Director, Regulatory Affairs Jobs in Cambridge, MA

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Join a dynamic team to lead regulatory project management, ensuring timely and compliant submissions to health authorities. Collaborate cross-functionally to align project goals, manage risks, and dri...

Join a team that's redefining operational excellence by leading quality assurance, compliance, and governance initiatives across segments, ensuring standards are met while fostering collaboration and...

Lead and optimize the compliance function with a strategic focus on regulatory readiness, risk management, and team development. Collaborate cross-functionally to ensure practical compliance embedded...

Lead the charge in quality operations, overseeing compliance and governance for external manufacturing partners, and ensure timely quality decisions for clinical and commercial products in a dynamic...

Drive global regulatory strategy for marketed products, ensuring compliance with local regulations. Collaborate across functions to support submissions and maintain market access, while guiding teams...

Join a dynamic team to deliver strategic CMC regulatory support across diverse therapeutic modalities, ensuring successful clinical trials, market registrations, and compliance. Build collaborative re...

Join a team that's shaping the future of regulatory strategy in biopharma. Lead cross-functional collaborations, guide regulatory submissions, and drive successful agency engagements for groundbreakin...

Lead the charge in developing global regulatory strategies for innovative immunology programs. Drive product approval processes, ensuring compliance and optimal labeling while managing complex project...

Lead the charge in global pricing and market access strategy for a rare disease portfolio, collaborating with cross-functional teams to ensure effective access and value proposition development for cu...

Lead the charge in ensuring quality compliance by executing risk-based audits, assessing adherence to GxP regulations, and driving continuous improvement while partnering with cross-functional teams t...

Join a dynamic team as a Regulatory CMC Senior Manager, driving global regulatory strategies, lifecycle management, and cross-functional collaboration to advance innovative products in a fast-paced en...

Join a team that's shaping the future of medical strategy for a key asset. Leverage deep therapeutic expertise, cultivate strategic partnerships, and drive compliance while aligning cross-functional t...

Transform partner audit experiences by leading cross-functional teams to streamline processes, enhance compliance, and drive timely resolutions. This role is pivotal in ensuring seamless collaboration...

Transform the future of patient safety by establishing robust procedures and policies that align with global Pharmacovigilance regulations. Collaborate cross-functionally to ensure compliance and effi...

Drive growth by leading a team of provider relations representatives, managing key provider relationships, and implementing strategies to enhance service offerings and revenue within the compounding p...

Shape the future of regulatory strategy for critical products. Leverage your expertise to oversee local regulatory submissions and ensure compliance while collaborating with global teams to optimize p...

Shape the future of regulatory excellence by leading global strategies for product approvals and compliance. Collaborate with cross-functional teams, drive market access, and provide critical risk-bas...

Elevate quality standards by leading CAPA investigations and driving cross-functional collaboration. This role demands analytical rigor and effective communication to resolve complex quality issues wh...

Unlock your potential as a key player in advertising and promotion compliance, guiding regulatory strategies and collaborating across teams to enhance product success in the pharmaceutical sector. Rea...

Join a team that's dedicated to regulatory compliance and product stewardship, leading efforts across markets in North America. Oversee daily operations, drive continuous improvement, and cultivate a...

Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

Lead oversight of pharmacovigilance operations, ensuring compliance with regulations and managing vendor deliverables. Drive ICSR quality and CAPA processes while mentoring staff and monitoring perfor...

Join a dynamic team as a strategic legal partner, providing expert counsel on regulatory, quality, and compliance matters for medical devices globally, while managing complex legal projects and advisi...