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Sr. Director, Regulatory Strategy
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-07-09
Listing for:
Scholarrock
Full Time
position Listed on 2026-07-09
Job specializations:
-
Management
Healthcare Management -
Healthcare
Healthcare Management
Job Description & How to Apply Below
Summary of Position
The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and implementation of the Global Strategy for assigned clinical and/or pipeline programs globally depending on the program. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan.
The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence.
- Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success.
- Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (
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