Senior Director, Regulatory Affairs
Company: THIRD ROCK VENTURES, LLC
Posted on: May 28, 2023
Senior Director, Regulatory Affairs at Relay Therapeutics We are
looking for a strategic regulatory leader to join our growing
regulatory team at Relay Tx. You will have the opportunity to
define and implement innovative regulatory strategies to expedite
the development and approval of our transformative pipeline. You
will serve as the regulatory lead on relevant project teams to
define and execute development strategies for developmental
programs. You will be the primary contact to interface with FDA and
will lead cross-functional teams to deliver domestic and
international regulatory submissions including IND, CTANDA and MAA
submissions. You will be coaching and mentoring junior regulatory
staff to support their development and enable program deliverables.
- You will work side by side with our Head of Regulatory Affairs
and your research and development colleagues to develop and
executeinnovative regulatory strategies for oncology development
programs, and you are responsible for obtaining regulatory
approvals for clinical investigations and marketing applications of
assigned programs and ensuring that development and post-marketing
activities comply with regulatory requirements.
- As a key strategic partner, you will advise relevant project
teams on what will be the ideal target product profile and
realistic label for the intended product, and contributes to design
and implementation of CMC, non-clinical and clinical development
plans, as well as CDx plans for the assigned programs. You will
play a key role to anticipate development risks and propose
mitigation plans from regulatory perspective.
- You will serve as the channel of communication with the
regulatory authorities as the development programs proceeds. You
will keep abreast of current legislation, guidelines and other
regulatory intelligence and we will rely on you to interpret
regulatory rules and exercise regulatory flexibility. You will
proactively anticipate what the regulatory authorities will require
to advance development and obtain regulatory approvals.
- You will lead cross-functional teams to prepare high quality
IND, CTA and NDA/MAA submissions for assigned programs to ensure
the regulatory dossiers are clear, consistent, and complete to
satisfy the regulatory framework and meet the company's strategic
- You will lead the preparation and conduct of meetings with FDA
and regulatory authorities outside of the US.You will be
responsible fordevelopment of robustbriefing packages and lead
meeting preparation to maximize outcomes of meetings with
- You will lead the efforts to plan and obtainregulatory
designations including but not limited to breakthrough therapy
designations,orphan drugdesignations. You will contribute to the
CDx strategy development and submissions in conjunction of
cross-functional team and CDx partners.
- You will provide oversight to the global regulatory activities
that are performed by our Clinical Research Organization (CROs) and
regulatory vendors. You will lead and mentor junior staff in the
regulatory team to support their development and enable program
deliverables. Your Background:
- 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
drug development and regulatory strategy. You have experience
interfacing with relevant regulatory authorities. It's not your
first rodeo, meaning you have experience successfully filing and
managing IND, CTA and NDA/MAA submissions. Experience in precision
oncology strategy and companion diagnostic (CDx)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. #LI-AM1 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!
Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Senior Director, Regulatory Affairs, Executive , Cambridge, Massachusetts
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