Senior Director, Regulatory Strategy and Operations
- Reporting to the Chief Medical Officer, you will join our Precision Medicine leadership team and guide the company’s regulatory strategy and operations.
- You will be accountable for developing and implementing the regulatory strategy and submissions required to progress our product candidates from non-clinical development through clinical development and registration.
- You will be responsible for coaching and mentoring our regulatory strategy and operations staff to support their growth and development.
- You will work side by side with our Chief Medical Officer and your clinical development colleagues to develop regulatory strategies for various development programs (from FIH through late-stage clinical trials).We will lean on you to lead the development and implementation of non-clinical and clinical regulatory strategy for projects in all stages of development.
- You will develop briefing packages, expedited program applications, orphan drug applications for meetings with FDA and other global health authorities.
- You will provide regulatory leadership and guidance to regulatory staff and project teams for the development of domestic and global regulatory submission documents.
- You will oversee the development of response strategies and submissions to regulators.
- You will integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
- You will ensure clinical and nonclinical programs are designed and implemented to meet regulatory requirements.
- You will be accountable for compliance with regulatory filing and reporting requirements.
- .You will attend and lead critical health authority meetings.
- We will depend on you to stay up to date on global regulatory changes that may impact asset development and keep us informed.
- You have earned your B.S and/or M.S. and bring 10+ years of relevant work experience in pharmaceutical regulatory affairs.
- You have advanced knowledge and experience in global oncology and non-oncology drug development and regulatory strategy. You have experience interfacing with relevant regulatory authorities -you have experience successfully filing and managing IND, CTA and NDA/MAA submissions. Experience in precision oncology strategy and companion diagnostic (CDx) development 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; you can propose innovative solutions to regulatory problems to ensure the efficiency and effectiveness of major regulatory submission processes.
- You have excellent written and verbal communication skills, a candid and articulate communicator, you can flex to different work styles, and believe that the best outcomes result from using the strengths of your team members.
- You have a "can do" attitude, and you are passionate about the impact of regulatory work on patients.
- You will be a coach and mentor to our junior staff to support their growth and development and you are passionate about empowering your team to shine.
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!