- Cambridge, Massachusetts, United States
- Hybrid
- Manager
- 8+ years
Responsibilities
- Lead or co‑lead for one RA CMC development and/or marketed product
- Provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs
- Contribute to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences)
- Oversee activities of junior regulatory personnel
- Build/maintain relationships globally and cross‑functionally
Requirements
- Bachelor's degree