- Our Pharmaceutical Development team continues to grow, and we are looking for a leader to guide our regulatory strategy and operations. As the first person in this role, you will have the opportunity to assist leadership 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 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: from assisting in managing and executing regulatory submissions and amendments to various regulatory authorities ensuring 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 to 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 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.
- It’s not your first rodeo, meaning you have successfully filed INDs and CTA’s before. NDA preparation and/or filing experience would be a bonus.
- 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.
- 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 full 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, 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 new breed of company at the intersection of computation and biotechnology that is committed to creating medicines that will have a transformative impact on patients.
We combine unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry, and biology. This integration illuminates – for the first time – the full mobility of a protein and provides key insights into how the dynamic nature of a protein’s conformation regulates function. The team at Relay is putting this principle into practice, with the aim of accelerating the development of medicines that will make a transformative difference in patients’ lives. We don't just stare hard problems in the face. We go out looking for them. Are you energized by attempting to do the impossible? We're looking for you.
At Relay, our team is driven by the ultimate collaboration across each of our drug discovery disciplines. Putting protein motion at the heart of drug discovery is a challenge, but we are confident that our team’s dedication and urgency will create opportunities that deeply impact the lives of the patients. Our initial programs are focused on developing therapeutics in oncology.
Relay Therapeutics is a private company launched in 2016 with financing from Third Rock Ventures and an affiliate of D. E. Shaw Research. To date the company has raised $520M from investors including Third Rock Ventures, SoftBank Vision Fund, GV, Casdin Capital, BVF Partners, EcoR1 Capital, Foresite Capital, Perceptive Advisors, Tavistock Group and an affiliate of D.E. Shaw Research.