22 Drug Regulatory Affairs Jobs in Norwood, MA - page 2
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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 23 days ago
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Senior Manager, Regulatory Affairs Editas Medicine - Cambridge, Massachusetts 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 5 days ago
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Director, PV Regulatory ONO PHARMA USA - Cambridge, MA, United States and management experience in the PV, Regulatory Affairs department of an established United States-based pharmaceutical company, having worked directly with the Food and Drug Administration (FDA) to successfully 24 days ago
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Director, US Regulatory Affairs, Ad/Promo & Labeling 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 23 days ago
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Regulatory Affairs Director, Oncology AstraZeneca - Waltham, Massachusetts, USA . Minimum Qualifications: Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience. A solid knowledge of regulatory affairs within at least 7 days ago
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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 17 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 26 days ago
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Consumer Safety Officer Food and Drug Administration - Arlington, Massachusetts Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Biological Products Operations (OBPO), which 10 days ago
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Director, Non-Clinical Toxicology MapLight Therapeutics, Inc. - Burlington, MA, United States Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND 20 days ago
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Director, Regulatory CMC Editas Medicine - Cambridge, Massachusetts 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 15 days ago
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