Regulatory Affairs Jobs in Quincy (MA)

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Search Results - Regulatory Affairs Jobs in Quincy (MA)

Director, Global Regulatory Affairs CMC

Takeda-Quincy (MA)-6 days ago

Overview In this role you lead and execute regulatory CMC strategies for Takeda’s products within GRA CMC, interfacing with cross-functional teams and Health Authorities. You drive regulatory submissions, ensure global compliance, and mentor team...

Regulatory Affairs Specialist - Remote

YO AI Labs-Boston, 8 mi from Quincy (MA)-5 days ago

Job Description Job Description Job Title: Regulatory Affairs Specialist Location: Remote Job Type: Contract Job Description We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing...

Sr Mgr, Regulatory Affairs

Baxter International-Quincy (MA)-1 week ago

Overview Senior Regulatory Affairs leader responsible for developing and executing regulatory strategies to enable timely market access and ongoing compliance across international markets, with strong US FDA expertise. You will coordinate cross...

Regulatory Affairs Specialist - Remote

YO AI Labs-Boston, 8 mi from Quincy (MA)-5 days ago

Drug Product Process Scientist - Small Molecule

Takeda-Quincy (MA)-3 days ago

sourcing, technology transfer, validation and network capability strategies • Lead cross-functional execution across Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain and external partners • Identify risks, opportunities...

Co-Op, Quality Assurance & Compliance

Moderna Therapeutics-Quincy (MA)-3 days ago

program in science-related fields or regulatory affairs • Interest in cGMP manufacturing, quality systems, batch records, deviation management, and inspection management • Strong written and verbal communication, detail-oriented, collaborative...

Product Manager / Senior Product Manager - Catastrophe Models

Verisk Analytics-Quincy (MA)-4 days ago

requirements across the lifecycle. • Perform competitive analysis and maintain market positioning frameworks to stay ahead. • Lead model launches and go-to-market activities with Marketing, Sales, Consulting, Client Services, and Regulatory Affairs...

Drug Product Process Scientist - Small Molecules

Takeda-Quincy (MA)-3 days ago

and operations • Coordinate integrated execution across Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain, and external partners • Define and execute manufacturing, sourcing, technical transfer, validation, and network capability...

Clinical Development Medical Director- Hepatology

GSK-Quincy (MA)-4 days ago

and adaptability • Clinical Development • Drug Regulatory Affairs • Evidence Based Decision Making...

Associate Director, Clinical Scientist

Ironwood Pharmaceuticals-Quincy (MA)-1 week ago

development, study planning, data review, and reporting, ensuring timely issue resolution and alignment with the Medical Director and study teams. You will collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Patient...