Latest Drug Regulatory Affairs jobs in Burlington, MA

19 Drug Regulatory Affairs Jobs in Burlington, MA

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
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 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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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
Consumer Safety Officer Food and Drug Administration - Stoneham, 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
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
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 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
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

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