The Opportunity:

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, CTA NDA and MAA submissions. You will be coaching and mentoring junior regulatory staff to support their development and enable program deliverables.

Your Role: 

• You will work side by side with our Head of Regulatory Affairs and your research and development colleagues to develop​ and execute innovative 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 goals.
• You will​ lead the preparation and conduct of meetings with FDA and regulatory authorities outside of the US. You will be responsible fordevelopment of ​robust briefing packages ​and lead meeting preparation to maximize outcomes of meetings with regulatory authorities.
• You will lead the efforts to plan and obtain ​regulatory designations including but not limited to breakthrough therapy designations, orphan drug designations. 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.

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