- Actalent (Greenfield, IN)
- Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist , you will play a crucial role in the ... + Collaborate with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers. + Participate in industry working groups to… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in...molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. +… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …Citizenship Required:** Yes **Job Description:** **GDIT's Military Health team is hiring a Regulatory Affairs Scientist to support the Office of Regulated ... support for FDA-regulated drug, biologic, medical device, and combination products.** **The Regulatory Affairs Scientist will ensure compliance with FDA… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... overseeing all analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... We are seeking a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... Analytical Operations department is seeking a highly motivated Senior Scientist to lead our impurities development team. The ideal...program. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... true to the best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About… more