- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… more
- Sumitomo Pharma (Albany, NY)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
