Senior Associate / Manager, Regulatory Affairs at Relay Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Dec, 25

Salary

0.0

Posted On

19 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Drug Development, Regulatory Submissions, Precision Oncology, Rare Disease, Companion Diagnostic, Problem-Solving, Communication Skills, Detail-Oriented, Organizational Skills, Collaboration, Regulatory Intelligence, Risk Identification, Meeting Preparation, Clinical Development, Strategic Planning

Industry

Biotechnology Research

Description

The Opportunity: We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will support the global regulatory lead to drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. Your Role: You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy. You will coordinate the preparation and submission of high quality domestic and global regulatory submission documents (e.g. IND, CTA, NDA/MAA), ensuring compliance with applicable regulations and internal standards. You will assist in the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to support successful outcomes of meetings. You will monitor for and integrate regulatory intelligence/guidelines into program strategies and contribute to risk identification and mitigation planning within development teams. You will support 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 2+ years of relevant experience. Advanced degree or education in a scientific field is a plus You are results-oriented and have working knowledge of the drug development process and regulatory submissions (IND, CTA, NDA/MAA, etc.) Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus You are a proactive problem-solver, capable of identifying solutions to regulatory challenges You have strong verbal and written communication skills, including the ability to present strategic regulatory topics to internal teams You are detail-oriented, organized, and able to work both independently and collaboratively in a fast-paced environment You are intellectually curious and eager to contribute to a growing team focused on innovation and patient impact #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

You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will coordinate the preparation and submission of high-quality domestic and global regulatory submission documents, ensuring compliance with applicable regulations and internal standards.