- Our Pharmaceutical Development team continues to grow, and we are looking for a leader to guide our regulatory strategy and operations. You will have the opportunity to lead with the development and implementation of our regulatory strategy for the timely development of investigational products.
- You will prepare domestic and international investigational new drug dossiers. So, be prepared to flex your writing skills as we will look to you to write and review our IND, NDA, CTA and MAA submissions.
- You will serve as the regulatory lead on relevant project teams and represent Relay Tx as the regulatory contact with relevant regulatory authorities.
- You will work side by side with our Senior Vice President, Pharmaceutical Drug Development and your clinical development colleagues to develop regulatory strategies for multiple oncology development programs (from FIH through late stage clinical trials).
- We will lean on you to lead the development and implementation of pre-clinical and clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
- You will develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities.
- We will rely on you to provide regulatory leadership and guidance to project teams for the development of domestic and global regulatory submission documents.
- You will develop 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
- We will look to you to support operational activities: You will from assisting in managing and executing regulatory submissions and amendments to various regulatory authorities
- You will ensure regulatory compliance with IND filing and reporting requirements
- Can you help us anticipate tomorrow, today? You will identify and assess regulatory risks for assigned projects or programs.
- Are you comfortable attending and contributing in Health Authority meetings? We need your presence here.
- Last but not least, as our first Regulatory teammate, 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 Ph.D. and have 10+ years of work experience in pharmaceutical regulatory affairs, or B.S/M.S. and bring 12+ years of work experience in pharmaceutical regulatory affairs
- Your previous colleagues would call you a subject matter expert. You have advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and Europe.
- Experience in precision oncology strategy is a plus
- It’s not your first rodeo, meaning you have experience successfully filing INDs and CTA’s before. NDA preparation and/or filing experience would be a bonus.
- You have strong communication skills, a candid and articulate communicator, you can flex to different work styles, and believe that the best outcomes result from leveraging the strengths of your team members.
- You have experience interfacing with relevant regulatory authorities.
- You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements, etc.
- You are a strategic thinker, you’re; capable of proposing innovative solutions to regulatory problems and can share stories to illuminate your creativity.
We believe in building balanced teams and a place where our people can be their best self every day. We encourage people from underrepresented backgrounds to apply.
Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
At Relay Tx, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's “Best Places to Work“ in 2017, the #1 place for small companies in 2018 & the #2 place for small companies in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line.
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!