Senior Regulatory Affairs Specialist Jobs in Cambridge, MA

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...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Empower your career by leading regulatory advertising initiatives, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging for marketed and pipeline...

Lead the charge in developing and executing CMC regulatory strategies for international submissions, ensuring compliance and guiding teams through complex regulatory landscapes in a dynamic, results-d...

Champion the training program and document control initiatives, ensuring compliance and effectiveness in quality systems. Collaborate with teams to enhance training materials and support onboarding, w...

Optimize trade compliance processes by leveraging analytics and collaboration across teams. Drive continuous improvement initiatives while ensuring adherence to customs regulations and enhancing opera...

Drive regulatory strategy across major programs, leading high-impact submissions and authority engagement. Collaborate with cross-functional teams to optimize clinical development and ensure complianc...

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

Unlock potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

Unlock potential by leading regulatory writing for complex submissions, mentoring junior writers, and driving departmental initiatives. Collaborate with cross-functional teams to ensure compliance and...

Join a dynamic team to oversee QC Raw Material activities, ensuring compliance with GMP standards. Drive continuous improvement and manage projects while collaborating across functions to support manu...

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...

Join us in leading contamination control and sterility assurance programs across multiple manufacturing sites, ensuring compliance and operational excellence while enhancing product quality and patien...

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...

Lead the charge in shaping regulatory operations by enhancing submission processes, governance, and systems. Drive high-quality global submissions while fostering collaboration and visibility across t...

Unlock potential by ensuring compliant cell therapy manufacturing through effective deviation investigations, CAPA implementation, and continuous improvement initiatives while collaborating with Quali...

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Lead the charge in Regulatory CMC for small molecule programs, driving strategic initiatives and global submissions. Collaborate with cross-functional teams to ensure compliance and support successful...

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...

Oversee quality assurance activities, ensuring compliance and product integrity. Execute QMS processes, manage product complaints, support DSCSA adherence, and collaborate with cross-functional teams...

Pioneer innovative regulatory strategies for global clinical development, leading cross-functional teams and ensuring compliance with health authority requirements. Drive submissions and represent the...