Manager, Regulatory Affairs

Responsibilities

• Develop and execute innovative regulatory strategies for programs from first-in-human through late-stage clinical development
• Coordinate preparation and submission of domestic and global regulatory documents including IND, CTA, NDA, and MAA
• Assist in preparing briefing packages and conducting meetings with health authorities
• Monitor regulatory intelligence and integrate guidelines into program strategies
• Support efforts to obtain regulatory designations such as breakthrough therapy, fast-track, and orphan drug designations
• Provide oversight to global regulatory activities performed by CROs and regulatory vendors

Requirements

• B.S. or M.S. degree
• 2+ years of relevant regulatory experience
• Working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA)
• Strong verbal and written communication skills
• Ability to work independently and collaboratively in a fast-paced environment

Preferred Qualifications

• Advanced degree or education in a scientific field
• Experience in precision oncology, rare disease, or companion diagnostics (CDx)

About the Company

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion, the company aims to effectively drug protein targets that have previously been intractable.