- Kelly Services (Rahway, NJ)
- …OF POSITION** The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical ... in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review...preparation and review of information required for development of regulatory CMC dossiers for new and existing… more
- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Regulatory Sciences Coordinator is responsible for coordinating and supporting the deliverables and continuous improvement projects of the CMC ... authorities are incorporated into the business. As a CMC Regulatory Sciences Coordinator, a...+ Program tracking: + Tracks the due dates for Specialist deliverables to help identify resource constraints before they… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …and clinicians in hematology, immunology, neurology, and transfusion medicine. The **Sr. Specialist for Regulatory Affair** **s** is responsible for ... FDA for the assigned products. + Thoroughly reviews the CMC dossier created by the GPOs to ensure it...Regulatory Affairs team Education/Experience: + BS/BA/MS degree in science . Minimum of 5 years of pharmaceutical industry experience,… more
Locations:
New Jersey,
New York