Director, Regulatory Affairs Jobs in Waltham, MA

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...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

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...

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...

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...

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...

Drive regulatory success by managing complex submissions globally, ensuring compliance with diverse requirements. Collaborate with cross-functional teams to guide product development and maintain up-t...

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...

Shape the future of product communication by delivering expert regulatory guidance, collaborating across departments, and ensuring compliance with FDA regulations to support brand initiatives and prom...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Manage regulatory strategies for AI-enabled medical imaging software, ensuring compliance across FDA and EU markets. Collaborate with cross-functional teams to facilitate submissions and lifecycle man...

Shape the future of pharmaceutical development by leading regulatory CMC strategies to support investigational and post-approval product success. Collaborate with cross-functional teams to ensure comp...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

Innovate and lead regulatory strategy for transformative gene therapies, shaping FDA and EU interactions. Collaborate cross-functionally to ensure compliance and accelerate patient access through exce...