Associate Director, Regulatory Affairs

Relay Therapeutics•Cambridge, MA

1d•$144,000 - $205,000

About The Position

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to 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. Your Role: 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 regualtory strategy for relevant products. You will be responsible for leading the preparation and submission of high quality domestic and global regualtory 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 regualtory 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 regualtory intelligence into the development strategies and ensuring compliance with regualtory 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. Your Background:

Requirements

B.S and/or M.S.
At least 5 years of increasing responsibility in regualtory affairs
Comprehensive knowledge of the drug development process
Demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.)
Experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility
Strategic thinker, capable of proposing innovative solutions to regulatory problems
Strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regualtory agencies
Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work

Nice To Haves

Advanced degree or education in a scientific field
Experience in precision oncology, rare disease and/or companion diagnostic (CDx)

Responsibilities

Define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline
Serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs
Be the primary contact to interface with FDA
Lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions
Develop and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products
Lead the preparation and submission of high quality domestic and global regualtory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators
Communicate with the global regualtory 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
Integrate your knowledge of current legislation, guidelines and other regualtory intelligence into the development strategies and ensuring compliance with regualtory filing and reporting requirements
Proactively identify regulatory opportunities and risks and proposing alternative approaches and mitigations to resolve development program challenges
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
Provide oversight to the global regulatory activities that are performed by our Clinical Research Organization (CROs) and regulatory vendors