Regulatory Affairs Specialist Jobs in Cambridge, MA

Join a dynamic team to enhance Quality Management Systems, ensuring compliance and supporting inspection readiness. Collaborate cross-functionally to maintain effective quality processes in a regulate...

Optimize product safety compliance by leading Safety Data Sheet generation, ensuring adherence to global regulations, and providing expert guidance to cross-functional teams while driving process impr...

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...

Drive regulatory excellence in medical devices and biologics, ensuring compliance and strategic submissions to FDA and international bodies. Collaborate across teams to support product development and...

Transform your career by leading global CMC regulatory strategies for innovative therapeutics. Collaborate across teams to navigate complex regulatory landscapes and drive the development of cutting-e...

Lead regulatory strategy and execution for IVD products, ensuring compliance and successful submissions. Collaborate across teams to shape development plans and manage regulatory risks, driving projec...

Optimize the promotional review process by coordinating cross-functional workflows, ensuring compliance, and facilitating timely approvals of marketing materials. Collaborate with internal and externa...

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

Champion regulatory strategy and submissions for clinical-stage radiopharmaceutical programs. Collaborate cross-functionally to ensure compliance and quality in regulatory communications, while leadin...

Champion regulatory excellence by leading cross-functional teams to ensure compliant submissions for clinical-stage radiopharmaceutical programs, driving strategic interactions with Health Authorities...

Transform the regulatory landscape by providing strategic leadership in a dynamic biotechnology environment. Collaborate with cross-functional teams to drive innovative RNA-based therapeutic developme...

Lead the charge in developing and executing regulatory strategies for US and Canada, ensuring compliance and effective communication with health authorities while supporting product commercialization...

Pioneer innovative regulatory strategies for biomaterials and biologics, guiding cross-functional teams to ensure compliance and accelerate product development. Lead submissions and lifecycle manageme...

Empower regulatory excellence by guiding cross-functional teams in compliance and strategy. Leverage deep FDA knowledge to influence promotional materials and ensure adherence to evolving regulations...

Unlock your potential as a Global Regulatory Leader, driving regulatory strategy and submissions for CNS projects. Collaborate with cross-functional teams, mentor junior staff, and ensure compliance w...

Lead the development and execution of global CMC regulatory strategies to support clinical trials and market applications, ensuring compliance with regulatory requirements throughout the product lifec...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...

Drive strategic CMC regulatory leadership for late-stage and marketed products, ensuring compliance and quality in submissions. Collaborate with cross-functional teams to influence outcomes and engage...

Lead global regulatory strategy for clinical-stage oncology programs, ensuring compliance and successful submissions. Collaborate cross-functionally to shape regulatory processes and drive innovative...

Champion quality assurance initiatives by overseeing product disposition and batch record reviews while driving compliance and continuous improvement in collaboration with cross-functional teams...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

Champion regulatory excellence by leading cross-functional teams, ensuring compliance, and driving successful oncology drug development through strategic planning and expert guidance...

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 regulatory project management by leading cross-functional teams to ensure timely execution of complex pharmaceutical and medical device initiatives, aligning with global regulatory standards a...