- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- 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
- Merck (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... supplies' + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve ... internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and… more