19 Drug Regulatory Affairs Jobs in Waltham, MA
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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 13 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 8 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 2 days ago
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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 15 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 5 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 17 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 6 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 5 days ago
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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 20 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 2 days ago
Top locations
- Cambridge, MA (12)
- Boston, MA (6)
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- Burlington, MA (2)
- Somerville, MA (1)
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- Massachusetts (6)