- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- Adecco US, Inc. (Swiftwater, PA)
- Adecco Healthcare & Life Sciences is hiring a contract hybrid Regulatory Affairs Specialist for our Pharmaceutical Manufacturing partner in Swiftwater, PA. ... upon meeting eligibility criteria Overview of the Position The Regulatory CMC Specialist will work... documents/dossiers to be dispatched to regulatory affairs functions for submissions * Coordinates CMC … more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Nov 14, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Thank you for your interest in our Sr ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Actalent (Cambridge, MA)
- … Submissions Specialist to manage submission-related activities, working closely with regulatory and CMC leads to create content plans and submission ... Job Title: Regulatory Submissions Specialist Job Description We...The ideal candidate will have a strong background in regulatory affairs and experience with IND and… more
- Novo Nordisk (Lexington, MA)
- …(statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs , Global Safety (GS), Bioanalysis, CMC and occasionally ... Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in… more