Manager, Regulatory Affairs
Relay Therapeutics
June 30, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Responsibilities:
- Support development and execution of innovative regulatory strategies from first-in-human through late-stage clinical development, including non-clinical and clinical regulatory strategy.
- Coordinate preparation and submission of domestic and global regulatory documents (e.g., IND, CTA, NDA/MAA) ensuring compliance with regulations and internal standards.
- Assist in preparation for and conduct of meetings with health authorities, including briefing packages and meeting preparation.
- Monitor and integrate regulatory intelligence/guidelines into program strategies; contribute to risk identification and mitigation planning.
- Support planning and obtaining regulatory designations (e.g., breakthrough therapy, fast-track, orphan drug) and contribute to CDx strategy development and submissions.
- Provide oversight to global regulatory activities performed by CROs and regulatory vendors.
Qualifications/Skills:
- B.S. and/or M.S.; 2+ years of relevant experience. Advanced degree/education in a scientific field is a plus.
- Working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA).
- Experience in precision oncology, rare disease, and/or companion diagnostic (CDx) is a plus.
- Proactive problem-solver for regulatory challenges.
- Strong verbal and written communication skills; ability to present strategic regulatory topics.
- Detail-oriented and organized; able to work independently and collaboratively in a fast-paced environment.
- Proactive, intellectually curious; eager to contribute to innovation and patient impact.
Estimated salary range: $100,000 - $143,000 (actual base salary depends on factors including education, experience, skills, and location).
- Support development and execution of innovative regulatory strategies from first-in-human through late-stage clinical development, including non-clinical and clinical regulatory strategy.
- Coordinate preparation and submission of domestic and global regulatory documents (e.g., IND, CTA, NDA/MAA) ensuring compliance with regulations and internal standards.
- Assist in preparation for and conduct of meetings with health authorities, including briefing packages and meeting preparation.
- Monitor and integrate regulatory intelligence/guidelines into program strategies; contribute to risk identification and mitigation planning.
- Support planning and obtaining regulatory designations (e.g., breakthrough therapy, fast-track, orphan drug) and contribute to CDx strategy development and submissions.
- Provide oversight to global regulatory activities performed by CROs and regulatory vendors.
Qualifications/Skills:
- B.S. and/or M.S.; 2+ years of relevant experience. Advanced degree/education in a scientific field is a plus.
- Working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA).
- Experience in precision oncology, rare disease, and/or companion diagnostic (CDx) is a plus.
- Proactive problem-solver for regulatory challenges.
- Strong verbal and written communication skills; ability to present strategic regulatory topics.
- Detail-oriented and organized; able to work independently and collaboratively in a fast-paced environment.
- Proactive, intellectually curious; eager to contribute to innovation and patient impact.
Estimated salary range: $100,000 - $143,000 (actual base salary depends on factors including education, experience, skills, and location).