Associate Director, Regulatory Affairs at Relay Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

205000.0

Posted On

29 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, FDA Interface, IND Submissions, CTA Submissions, NDA Submissions, MAA Submissions, Cross-functional Team Leadership, Regulatory Intelligence, Risk Mitigation, Regulatory Designations, CRO Oversight, Scientific Interpretation, Strategic Thinking, Verbal Communication, Written Communication

Industry

Biotechnology Research

Description

The Opportunity: 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: You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regualtory 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 regualtory agencies. Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work. Estimated Salary Range: [$144,000 - $205,000]. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location. #JO1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Responsibilities

This role involves defining and implementing innovative regulatory strategies to expedite pipeline development and serving as the global regulatory lead to formulate and execute development strategies for various programs. The individual will lead cross-functional teams in preparing and submitting domestic and international regulatory documents like IND, CTA, NDA, and MAA.