Manager, Regulatory Affairs

The Opportunity:

We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will  ​contribute to the development and execution of innovative regulatory strategies to support the advancement  of our transformative pipeline. You will support the global regulatory lead to ​drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.

Your Role: 

• You will work closely with research and development colleagues to support the development​ and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy.
• You will coordinate the preparation and submission of high quality domestic and global regulatory submission documents (e.g. IND, CTA, NDA/MAA), ensuring compliance with applicable regulations and internal standards.
• You will assist in the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to support successful outcomes of meetings.
• You will monitor for and integrate regulatory intelligence/guidelines into program strategies and contribute to risk identification and mitigation planning within development teams.
• You will support the efforts to plan and obtain ​regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions.
• You will provide oversight to the global regulatory activities ​that are performed by our Clinical Research Organization (CROs) and regulatory vendors.

Your Background: 

• You have earned your B.S and/or M.S. and bring 2+ years of relevant experience.  Advanced degree or education in a scientific field is a plus
• You are results-oriented and have working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA, etc.)
• Experience in precision oncology, rare disease​ and/or companion diagnostic (CDx) is a plus
• You are a proactive problem-solver, capable of identifying solutions to regulatory challenges
• You have strong verbal and written communication skills, including the ability to present strategic regulatory topics to internal teams