- 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
- ThermoFisher Scientific (New Brunswick, NJ)
- …company, all while maintaining full-time benefits. **Key responsibilities:** As a Senior Scientist, you will be part of the Analytical Regulated Testing ... Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.... inspections. + Effective teamwork and communication with the CMC sub teams to ensure all API and drug… more
- Merck (Rahway, NJ)
- …to the information that they need. + Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more