19 Drug Regulatory Affairs Jobs in Massachusetts
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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 3 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 6 days ago
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Pharmaceutical Program Manager The Fountain Group LLC - Cambridge, Massachusetts , Clinical Research, Regulatory, CMC, Marketing or other drug development related function Description: As part of the GMSO Program Management team, you will report to the Strategy & Operations Lead 3 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 7 days ago
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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 6 days ago
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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 18 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 9 days ago
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Senior Director/Director, Global Regulatory Affairs Lead (remote) Corbus Pharmaceuticals - Norwood, MA, United States in Regulatory Affairs Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA 9 days ago
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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 21 days ago
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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 13 days ago
Top locations
- Cambridge, MA (12)
- Boston, MA (6)
- Watertown, MA (3)
- Burlington, MA (2)
- Waltham, MA (2)
- Somerville, MA (1)
- Norwood, MA (1)