Director, Regulatory Affairs Jobs in Cambridge, MA

Shape the future of ophthalmology by leading a global regulatory team, defining strategies for drug development, and ensuring compliance with health authorities. Join us as we navigate complex challen...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

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

Champion regulatory excellence for high-risk implantable devices internationally, engaging with global regulators, driving compliance, and leading cross-functional teams to ensure successful market ac...

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...

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...

Play a key role in advancing regulatory strategies that ensure compliance with laws while supporting development programs. Collaborate cross-functionally to manage submissions and maintain high-qualit...

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...

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...

Champion regulatory excellence by guiding project teams, developing global strategies, managing submissions, and ensuring compliance with FDA and international regulations while navigating complex env...

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...

Drive regulatory excellence for promotional activities in a dynamic, compliance-focused environment. Lead cross-functional collaboration to ensure alignment with FDA regulations and corporate objectiv...

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 the potential of innovative therapies by leading global regulatory CMC strategies, ensuring compliance and quality in regulatory applications and submissions to health authorities for cutting-e...

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

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...

Join us to lead regulatory review of promotional materials, ensuring compliance with FDA regulations. Collaborate with cross-functional teams to enhance product messaging and contribute to the success...

Redefine global regulatory strategy by leading complex cardiovascular programs, driving optimal results with minimal oversight while engaging with global regulatory agencies for timely approvals and c...

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...

Lead regulatory support for Neurology and Oncology agents, driving strategies and submissions for global approvals. Collaborate across teams to enhance development timelines and ensure compliance with...

Oversee regulatory strategies for Neurology and Oncology product registrations, ensuring compliance and successful interactions with health authorities. Provide support across product lifecycles, enha...

Optimize regulatory strategies and compliance globally by leading cross-functional projects, guiding teams, and liaising with health authorities throughout the drug development lifecycle to ensure suc...

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...