Senior Regulatory Affairs Specialist Jobs in Boston, MA

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 quality assurance initiatives across GxP operations, driving impactful metrics and analyses. You'll collaborate independently on validations, managing documentation, and ensuring compl...

Champion regulatory excellence by leading cross-functional teams in strategic planning and execution of submissions for CNS therapies, ensuring compliance and alignment with global health authorities...

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...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

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...

Lead regulatory strategies for advertising and promotion in the pharmaceutical sector. Collaborate with cross-functional teams to address complex issues, ensuring compliance and maximizing product imp...

Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...

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...

Optimize global regulatory activities for medical devices, ensuring compliance in labeling, UDI, and product data. Collaborate with cross-functional teams to support product registrations and maintain...

Drive compliance excellence by leading the development and oversight of regulatory frameworks across diverse functions, ensuring alignment with global standards and fostering continuous improvement th...

Manage regulatory strategies for global product approvals, ensuring compliance and collaboration across teams. Lead submission activities for medical devices, fostering a high-performance culture whil...

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...

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...

Empower your career by leading global regulatory strategies for medical devices and diagnostics. Collaborate with cross-functional teams to ensure compliance and drive market access while mentoring ot...

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...

Join a dynamic team to manage post-market product safety and risk management. Collaborate with cross-functional groups to ensure compliance and execute end-to-end surveillance processes while driving...

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

Manage regulatory activities for advertising and promotion, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging and materials that align with com...

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...

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...

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...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...