Relay Therapeutics · 20 hours ago
Associate Director, Regulatory Affairs
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$144K/yr - $205K/yr
5+ years expRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. They are looking for a strategic regulatory leader to define and implement innovative regulatory strategies, serve as the global regulatory lead on project teams, and ensure compliance with regulatory filing and reporting requirements.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs
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.)
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
Preferred
Advanced degree or education in a scientific field is a plus
Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus
Company
Relay Therapeutics
Relay therapeutics is a developer of an allosteric drug-discovery platform intended to apply computational techniques to protein motion.
51-200 employees
H1B Sponsorship
Relay Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (2)
2022 (5)
2021 (6)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.4BKey Investors
Nextech InvestSoftBank Vision FundBiotechnology Value Fund
2024-09-10Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $30M
2022-09-12Post Ipo Equity· $300M
Leadership Team
Sanjiv Patel
President and CEO
Imogen Pryce
Chief Operating Officer, R&D
Recent News
2025-12-16
2025-12-12
Company data provided by crunchbase