Regulatory Affairs Manager Jobs in Boston, MA

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Lead regulatory strategies for CMC submissions and compliance in global projects. Collaborate with cross-functional teams to ensure accurate submissions and establish key relationships with authoritie...

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...

Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...

Drive regulatory compliance for innovative products by leading global strategies. Collaborate cross-functionally to ensure market readiness and sustain products throughout their lifecycle while mainta...

Unlock your potential as a Senior Manager leading regulatory submissions for biologics. Collaborate across teams, ensuring high-quality documentation for global approvals while navigating complex chal...

Drive strategic CMC regulatory activities for biopharmaceuticals, managing complex projects and documentation, while ensuring compliance, risk mitigation, and collaboration across internal and externa...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Transform global regulatory strategies for oncology programs, leading cross-functional teams and ensuring timely submissions and approvals while developing high-caliber regulatory talent...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

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 excellence by leading teams to develop successful strategies for biotech and pharmaceutical projects, ensuring compliance with FDA and global agencies while enhancing innovati...

Empower global regulatory strategy for ophthalmology programs. Lead and develop a high-performing team to ensure alignment with drug development and commercialization goals, while representing the org...

Tackle regulatory challenges by overseeing global quality compliance support, including managing audit logistics, controlled documents, training, and CAPA. Ensure adherence to quality standards while...

Champion the GxP Quality Systems by ensuring compliance and effectiveness through improved processes, training initiatives, and rigorous documentation. Engage cross-functional teams to maintain qualit...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Develop innovative global regulatory strategies for medical devices, ensuring compliance throughout the product lifecycle while collaborating with cross-functional teams and regulatory agencies to sup...

Advance your career by developing global regulatory strategies for medical devices, managing submissions, and guiding cross-functional teams to ensure compliance while fostering strong relationships w...

Shape the future of regulatory strategy and execution, driving high-quality submissions and interactions with global health authorities throughout the drug development lifecycle, ensuring adherence to...

Shape the future of regulatory excellence by managing global submissions, ensuring compliance across the drug development lifecycle, and collaborating across teams to facilitate strong health authorit...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

Collaborate to lead regulatory projects, ensuring compliance with state and federal standards while enhancing internal processes and fostering strong stakeholder relationships for timely project compl...

Shape the future of drug development by leading cross-functional CMC regulatory projects, mentoring talent, and influencing decision-making to ensure compliance and excellence in pharmaceuticals...

Unlock potential by leading regulatory CMC strategies for late-stage small molecule development. Collaborate with cross-functional teams to ensure compliance with global standards while driving qualit...

Lead and manage CQV activities for biopharmaceutical projects, ensuring compliance with cGMP and regulatory standards. Collaborate cross-functionally to oversee project execution, while guiding teams...