Manager, Regulatory Affairs

Regulatory Jobs; Cambridge (MA); On-site; USD 100,000 - 143,000; Full time

Job summary

Relay Therapeutics is seeking a motivated regulatory professional to join our growing team. You will support the development and execution of regulatory strategies to advance our transformative pipeline and collaborate with cross-functional teams to deliver domestic and international submissions including IND, CTA, NDA/MAA.

You will coordinate preparation of high-quality submission documents, assist in meetings with health authorities, and monitor regulatory intelligence to mitigate risks.

Qualifications

• 2+ years of regulatory experience in drug development.
• Familiarity with global regulatory submissions (IND, CTA, NDA/MAA).
• Experience collaborating with R&D, clinical, and QA teams.

Responsibilities

• Support development and execution of regulatory strategies for programs from FIH to late-stage.
• Coordinate preparation and submission of regulatory documents (IND/CTA/NDA/MAA) worldwide.
• Assist in meetings with health authorities and prepare briefing packages.
• Monitor regulatory intelligence and update program strategies accordingly.
• Assist in pursuing regulatory designations and CDx strategy development.
• Oversee regulatory activities performed by CROs and vendors.

Skills

Regulatory submissions

IND/CTA/NDA/MAA experience

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree or higher in a scientific field

Job 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

Estimated Salary Range

[$100,000 - $143,000].

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.

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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 partsfearlessandrelentless, 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!