What are the responsibilities and job description for the Director/ Sr. Director Regulatory Affairs position at Discover International?
We're currently partnering with a dynamic and fast-growing biotech company that is seeking to add a Director / Sr Director, Regulatory Affairs to its leadership team. This is a unique and exciting opportunity as the company is making significant strides in developing an innovative Auto-Immunology focused pipeline.
Key Responsibilities :
- Global Health Authority Experience (FDA, EMA, PMDA etc.)
- Accountable for the development and implementation of global regulatory strategies throughout the development of programs (e.g., regulatory meeting materials, INDs, NDA / BLAs, CTAs, MAAs, responses to regulatory inquiries, IND Safety reports, etc.)
- Collaborate with other functions to plan and execute an effective regulatory strategy in alignment with the overall development and / or lifecycle plan.
Experience :
