Regulatory Affairs Jobs in Somerville (MA)
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Planet Pharma-Somerville (MA)
programs through Phase 1 and Phase 2 development in the U.S., EU, and UK.This is a hands-on role for someone who can think strategically, work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows.Key...
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Merida Biosciences-Cambridge, 2 mi from Somerville (MA)
Job Description
Job Description
Description:
Sr. Director, Regulatory Affairs
At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources...
Arbor Biotechnologies-Somerville (MA)
forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!About the Role: The Director of Regulatory Affairs is responsible...
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Relay Therapeutics-Somerville (MA)
and commercialization.Responsible for leading and coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.Independently defines CMC content (data and documentation) requirements for regulatory submissions...
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Moderna Therapeutics-Somerville (MA)
enterprise data governance, define business capabilities, and partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital, and external technology partners to continuously improve regulatory business...
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Moderna Therapeutics-Somerville (MA)
to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as a novel drug modality. The Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory...
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Integrated Resources-Somerville (MA)
and integrate the external landscape, including competition, regulatory evolution, and advocacy insights, into program planning. Lead coordination across core functions including Clinical Development, Regulatory Affairs, Medical and Patient Engagement, Market...
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Moderna Therapeutics-Somerville (MA)
to successfully contribute to both early and late-stage clinical development programs. This will involve close collaboration with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial.Pay & BenefitsAt Moderna, we...
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Katalyst Healthcares & Life Sciences-Boston, 3 mi from Somerville (MA)
various communication channels, enhancing business relationships Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning...
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Repertoire Immune Medicines-Watertown (MA), 4 mi from Somerville (MA)
Immune Medicines is seeking an experienced Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and regulatory lead for its clinical-stage oncology programs.
The Director will own global regulatory strategy...
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