Job Description
About the Role:
Provides strategic regulatory leadership of programs in a therapeutic area, overseeing all regulatory activities across the product lifecycle, and coordinating with cross‑functional partners.
Responsibilities
- Drive collaboration with Clinical, Quality, Drug Safety & Pharmacovigilance, Legal, Government Affairs & Public Policy, and Patient Advocacy to integrate regulatory perspectives.
- Devote significant time to talent and workforce development, and set the tone for the regulatory group from a leadership perspective.
- Perform due diligence activities and serve as a trusted advisor across the company, recognized as an external expert.
- Member of the Regulatory Strategy Leadership Team, contributing to strategy development and execution, and strengthening organization capabilities.
- Represent regulatory strategy at the therapeutic and Development & Market Strategy Team levels, and in enterprise governance f...