Regulatory Affairs Manager Jobs in Cambridge, MA

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

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...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Join a team that's shaping the future of drug development by driving innovative regulatory strategies to ensure compliance with global health authority guidelines and supporting the advancement of tra...

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...

Oversee innovative regulatory strategies to support transformative clinical programs. Collaborate with cross-functional teams to ensure the preparation of high-quality regulatory submissions while dri...

Champion innovative regulatory strategies for biopharma products, driving compliance and collaboration across teams to advance therapeutic development and ensure successful market entry...

Take ownership of QA operations in radiopharmaceutical manufacturing, ensuring cGMP compliance, conducting audits, resolving quality events, and fostering a culture of continuous improvement within cr...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Contribute to regulatory strategy by guiding cross-functional teams through product development, ensuring compliance with regulatory requirements for medical devices and AI technologies while facilita...

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Lead the charge in transforming global regulatory strategies into successful outcomes. Oversee regulatory activities and empower teams to ensure quality compliance, timely delivery, and robust cross-f...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

Champion regulatory compliance by managing global submissions, ensuring adherence to laws and guidelines. Collaborate across teams to develop strategies, optimize processes, and maintain effective age...

Join a team that's redefining global regulatory strategies. Lead critical CMC submissions and leverage your expertise to navigate the complex landscape of Pharma/Biotech, while mentoring talent and dr...

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...

Unlock potential by leading regional regulatory strategies for innovative products. Collaborate effectively with global teams, ensuring compliance and fostering strong relationships with health author...

Drive regulatory excellence by ensuring compliance for product submissions and collaborating across teams to support marketed products and development programs while fostering high performance and inn...

Join our dynamic team to lead international regulatory submissions for innovative digital health technologies, ensuring compliance across global markets and collaborating cross-functionally for succes...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Lead global regulatory strategies for investigational products, coordinating submissions and navigating compliance. Collaborate across functions to deliver timely and accurate regulatory guidance, ens...