Associate Director, Regulatory Affairs

4 weeks ago

Cambridge, United States Softbank Investment Advisers Full time

Company Address: 399 Binney Street, 2nd Floor, Cambridge, MA , 02142About Relay Therapeutics Relay Therapeutics is committed to creating medicines that will have a transformative impact on patients by building a unique discovery platform centered on understanding how the conformation of proteins relate to function. About Relay Therapeutics Relay Therapeutics is committed to creating medicines that will have a transformative impact on patients by building a unique discovery platform centered on understanding how the conformation of proteins relate to function.Job 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. You will be coaching and mentoring junior regulatory staff to support their development and enable program deliverables.Your Role:You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical 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.You will lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.Your Background: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.#JO1About Relay TherapeuticsRelay 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 partsfearlessandrelentless, with a shared passion for working collaboratively in intellectually stimulating environments. If youre 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#J-18808-Ljbffr

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