Director, Regulatory Affairs Jobs in Cambridge, MA

Deliver comprehensive regulatory submissions and ensure compliance with FDA and global standards. Contribute expertise in the medical device field while collaborating with cross-functional teams on in...

Oversee the regulatory strategy for biologics and ATMPs, driving global compliance and alignment across functions. Lead a team in managing submissions, approvals and lifecycle activities in a fast-pac...

Lead the CMC regulatory strategy for biologics and ATMPs, overseeing resources and alignment with technical development. Foster collaboration for timely approvals and lifecycle progress in a fast-pace...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Lead the US Promotional Review Team to ensure compliance with FDA regulations while providing strategic guidance on promotional strategies and maintaining high standards in material evaluations across...

Drive global regulatory strategies for product development, ensuring compliance with health authority requirements while aligning with corporate goals. Provide leadership in regulatory activities and...

Join a dynamic team to drive CMC regulatory strategies and oversee submissions in the pharmaceutical sector. Lead experts in navigating complex regulatory environments while ensuring compliance and ef...

Lead the development and execution of US regulatory strategies, ensuring compliance and expedited pathways for innovative therapies. Collaborate with global teams and regulatory bodies to drive produc...

Join our dynamic Regulatory Affairs team to lead global strategies in drug development, ensuring impactful outcomes for innovative therapies in the Cardiovascular, Renal, and Metabolism sectors. Drive...

Advance global regulatory CMC strategies and lead submissions throughout the product lifecycle. Collaborate across project teams to ensure compliance and success in drug development and commercial ope...

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...

Lead the charge in optimizing manufacturing and quality operations, ensuring safety and efficiency while driving growth and compliance across dynamic diagnostic production environments. Shape strategi...

Drive comprehensive global pharmacovigilance efforts, ensuring safety compliance, signal detection, and collaboration across multiple departments to support innovative therapy development and regulato...

Lead and manage a global Pharmacovigilance audit program, ensuring compliance with regulations and industry best practices. Collaborate with cross-functional teams to enhance processes and drive conti...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Lead the charge in shaping global regulatory strategy and submission planning, ensuring compliance and driving successful outcomes for development-stage indications across the product lifecycle in a d...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Join a team that's redefining internal audit excellence by designing and executing a strategic risk-based audit plan, enhancing governance, and driving continuous improvement across global operations...

Champion operational excellence and strategic partnerships in the clinical research space. Drive financial performance and enhance client satisfaction while leading high-performing teams to achieve su...

Lead and innovate in managing complex CMC projects, ensuring regulatory compliance while driving strategic direction. Collaborate with cross-functional teams and represent the organization to key stak...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Lead the charge in global Pharmacovigilance Operations, ensuring strategic compliance, operational excellence, and inspection readiness to support product growth and regulatory success in a dynamic en...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Drive regulatory strategies and compliance for high-risk medical devices, ensuring successful market approval and navigating complex global regulations while collaborating with cross-functional teams...

Accelerate progress at drug product manufacturing by leading quality assurance efforts, ensuring compliance, and driving continuous improvement across GxP activities for successful late-stage developm...