Latest Drug Regulatory Affairs jobs in Lexington, MA

19 Drug Regulatory Affairs Jobs in Lexington, MA

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 2 days ago
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 5 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 14 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 2 days ago
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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 10 days ago
Consumer Safety Officer Food and Drug Administration - Arlington, Massachusetts the series/grade in question. See the Required Documents section for full details... This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Medical Products 104604.0-135987.0 15 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 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 9 days ago
Senior Medical Director, Oncology Asset Development Team Merck - Boston, MA the activities of Clinical Scientists in the execution of clinical studies Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage 17 days ago
Executive Director, Medical Writing MapLight Therapeutics, Inc. - Burlington, MA, United States , in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: Reporting to the VP, Regulatory Affairs 21 days ago

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