Latest Drug Regulatory Affairs jobs in Watertown, MA

17 Drug Regulatory Affairs Jobs in Watertown, MA

Senior Director, CMC HireMinds - Watertown, MA, United States development and manufacturing plans at external partners. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA) Collaborate with the Project Management 7 days ago
VP, Regulatory Affairs & Quality Vigil Neuroscience - Watertown, MA, United States the lives of patients and their families. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements 14 days ago
Senior Manager, Regulatory Affairs Editas Medicine - Cambridge, MA and advanced degree preferred. Minimum of 7+ years’ experience in drug development and a minimum 4+ years in regulatory affairs. Prior BLA, sBLA, NDA, sNDA, or MAA experience is preferred. Prior IND, CTA 16 days ago
Associate Director, US Regulatory Affairs, Advertising & Promotion Proclinical Staffing - Cambridge, MA, United States Regulatory Affairs representative, you will work with brand on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies 4 days ago
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Head of Drug Substance/CMC Lead Cellarity - Somerville, MA, United States development, medical affairs, new product planning, regulatory affairs, and corporate communications. Represent drug substance holistically internally and externally as needed. Activities include due diligence 4 days ago
Senior Director, Global Regulatory Strategy, Therapeutic Area Lead Biogen - Cambridge, Massachusetts, USA Required Skills: 15+ years of experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry. 5 years of leadership experience in a regulatory affairs management role 19 days ago
Regulatory Manager BostonGene - Waltham, MA, United States . Provide regulatory support for due diligence activities related to external diagnostic companies. Qualifications PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering. 6 12 days ago
Senior Director, Head of Drug Substance Astria Therapeutics, Inc. - Boston, MA, United States , and enhance strategic relationships with CDMO and other partners to advance Astria’s patient-guided drug development pipeline. Provide strategic and operational oversight, content creation of all regulatory 11 days ago
Director, Regulatory CMC Editas Medicine - Cambridge, MA and advanced degree preferred with a minimum of 10 years’ experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs. Experience with both US FDA and EMA with drugs 26 days ago
VP, Early Clinical Development Astria Therapeutics, Inc. - Boston, MA, United States Development, Clinical Operations, Regulatory Affairs, Nonclinical Development, Pharmaceutical Sciences, Discovery and Translational Sciences and other functions in driving asset and company strategy to fruition 12 days ago

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