Senior Manager, Regulatory Affairs
Nuvalent, Inc.Cambridge, Massachusetts, United States
Posted May 5, 2026
160000 - 185000 USD
Full Time
About the Company
Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Job Description
Senior Manager, Regulatory Affairs role at Nuvalent, a company working on selective medicines for cancer treatment, requiring regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA.
Requirements
- Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy;
- Supports preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.)
- Provides regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning)
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement savings plan
- Generous paid time off (including a summer and winter company shutdown)
- Relocation Assistance
