Director, Regulatory Affairs Jobs in Boston, MA

Empower your career by managing complex regulatory projects, ensuring compliance, and guiding cross-functional teams to achieve timely approvals and strategic goals in the biotechnology sector...

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...

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

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...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

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...

Unlock potential by leading global regulatory CMC activities, developing strategies for product lifecycle management, and collaborating across teams to ensure successful agency submissions. Drive tran...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...