Director, Regulatory Affairs Jobs in Cambridge, MA

Unlock your potential as a Global Regulatory Leader, driving regulatory strategy and submissions for CNS projects. Collaborate with cross-functional teams, mentor junior staff, and ensure compliance w...

Drive regulatory strategy for early programs, leading cross-functional teams to ensure timely submissions to health agencies. Collaborate with global leads to navigate complex regulatory landscapes an...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Champion regulatory strategy and submissions for clinical-stage radiopharmaceutical programs. Collaborate cross-functionally to ensure compliance and quality in regulatory communications, while leadin...

Champion regulatory excellence by leading cross-functional teams to ensure compliant submissions for clinical-stage radiopharmaceutical programs, driving strategic interactions with Health Authorities...

Architect innovative regulatory strategies for CMC in cell therapy, guiding teams and leading submissions throughout product development, ensuring compliance and successful health authority interactio...

Transform your career by leading global CMC regulatory strategies for innovative therapeutics. Collaborate across teams to navigate complex regulatory landscapes and drive the development of cutting-e...

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Partner with us to drive regulatory compliance strategies that support innovative therapies. Collaborate cross-functionally to ensure timely submissions and adherence to regulations while enhancing op...

Transform regulatory affairs by leading global strategy for oncology programs. Partner cross-functionally to navigate IND submissions and health authority interactions, ensuring successful Phase 1 and...

Contribute to regulatory CMC strategies for drug development and commercialization. Lead global submissions, ensure compliance with health authority standards, and engage cross-functional teams for ri...

Empower regulatory excellence by supporting compliance activities, SOP maintenance, and cross-functional collaboration. Drive inspection readiness and enhance operational efficiency in a fast-paced, g...

Transform regulatory strategies to ensure compliance for innovative medical devices while collaborating with cross-functional teams on product development and clinical studies. Drive timely submission...

Champion regulatory strategy and execution for early-stage development programs, serving as the Global Regulatory Lead and primary contact with health authorities to ensure compliance and effective en...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Take ownership of regulatory advertising and promotion strategies, ensuring compliance with FDA requirements and alignment with corporate goals. Lead cross-functional collaborations in a fast-paced, d...

Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Join us to lead global CMC regulatory strategies for cell and gene therapy products, ensuring compliance with global regulations while supporting the product lifecycle from development to registration...

Drive regulatory excellence in medical devices and biologics, ensuring compliance and strategic submissions to FDA and international bodies. Collaborate across teams to support product development and...

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

Shape global Regulatory CMC strategies for gene therapy products, ensuring compliance and successful submissions. Collaborate with cross-functional teams to drive projects from clinical trials to comm...