Director, Regulatory Affairs Jobs in Cambridge, MA

Optimize global regulatory strategy for cutting-edge cell therapies, leading high-impact programs from development through licensure. Collaborate with teams, ensure competitive pathways, and drive pat...

Shape compliance strategies across hardware and biotech sectors, ensuring products meet global regulatory standards and collaborating with cross-functional teams to drive innovative solutions and main...

Elevate your career by leading clinical contracts strategy to drive global trials. Collaborate with diverse teams, shape negotiation approaches, and ensure compliance while developing a high-performin...

Unlock potential by leading global regulatory strategy for innovative gene editing therapies. Drive submissions, engage with health authorities, and shape evidence generation in a fast-paced biotech e...

Transform global GxP compliance by leading a high-performing Quality team, overseeing audits, inspection readiness, and strategic initiatives to ensure effective governance across the organization's Q...

Empower our commercial legal function by providing strategic legal guidance on pre-launch and market access initiatives. Collaborate across teams to ensure compliance and support successful product la...

Lead a dynamic Quality Control Analytics team, ensuring timely testing and results for GxP manufacturing. Collaborate on process evaluations, drive continuous improvement, and foster a strong quality...

Support scientific operations across research programs, managing data rooms and IP workflows. Collaborate with leaders to ensure program accuracy and readiness, driving process improvements in a fast...

Lead the charge in managing pre-market regulatory activities to ensure compliance with US FDA, Health Canada, and EU IVD regulations. Collaborate with design teams, prepare submissions, and review pro...

Contribute to innovative global regulatory strategies ensuring product compliance for the pharmaceutical portfolio. Drive regulatory leadership, manage agency interactions, and enhance internal proces...

Lead the charge in shaping global EHS3 strategy, ensuring compliance and operational excellence across diverse functions while driving transformational initiatives and enterprise governance frameworks...

Lead the charge in regulatory operations, ensuring timely, high-quality submissions to global health authorities. Collaborate with cross-functional teams to manage project timelines, risks, and compli...

Drive the future of oncology regulatory affairs by leading global strategies, managing submissions, and collaborating with cross-functional teams to ensure compliance and successful product registrati...

Elevate the quality management systems by overseeing compliance, driving continuous improvement, and leading cross-functional efforts to harmonize processes in a regulated environment, ensuring effect...

Shape the future of drug substance development by leading regulatory strategies for starting materials. Collaborate cross-functionally and ensure compliance with global regulations to support late-sta...

Shape global regulatory strategies by providing leadership and expertise in drug development. Collaborate with teams to ensure compliance and influence regulatory authorities for better outcomes...

Architect quality strategies and lead a high-performing Quality Control team overseeing testing, compliance, and laboratory operations. Collaborate across functions to ensure timely product release wh...

Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...

Unlock potential by leading global regulatory strategy and product quality for a biopharmaceutical portfolio. Collaborate across functions to ensure compliance, drive innovation, and enhance operation...

Shape the future of clinical trials by leading site monitoring efforts, ensuring compliance, and fostering collaboration across teams. Drive quality and efficiency in trial execution while mentoring j...

Elevate clinical trial success by overseeing site monitoring, ensuring compliance, and providing leadership. Collaborate with cross-functional teams to address site issues, enhance recruitment, and ma...

Accelerate clinical trial success by leading site monitoring efforts, ensuring compliance, and providing expert guidance to the CRA team. Collaborate cross-functionally to resolve issues and enhance s...

Lead clinical trial monitoring efforts, ensuring compliance and quality. Collaborate with cross-functional teams to address site issues, manage budgets, and provide oversight. Drive successful study e...

Transform regulatory strategies for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Lead complex submissions and collaborate across teams to drive successfu...

Champion the future of Regulatory Strategy for groundbreaking mRNA vaccine programs. Lead strategic direction and ensure compliance with global health agencies, while driving innovative regulatory ini...