Associate Director, Regulatory Affairs

Role Summary

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions.

Responsibilities

• You will work side by side with your regulatory and research and development colleagues to develop and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regulatory strategy for relevant products.
• You will be responsible for leading the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators.
• You will be responsible for communicating with the global regulatory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings.
• You will be responsible for integrating your knowledge of current legislation, guidelines and other regulatory intelligence into the development strategies and ensuring compliance with regulatory filing and reporting requirements.
• You will be responsible for proactively identifying regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges.
• You will lead 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.

Qualifications

• You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
• You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.).
• Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus.
• You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility.
• You are a strategic thinker, capable of proposing innovative solutions to regulatory problems.
• You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies.
• Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work.

Education

• B.S. or M.S. in a scientific field.