AD / Director, Regulatory Affairs

Relay Therapeutics • Cambridge, MA

368d

About The Position

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 global regulatory lead on relevant project teams to formulate 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.

Requirements

• B.S and/or M.S. with at least 5 years of increasing responsibility in regulatory affairs.
• Comprehensive knowledge of the drug development process and a demonstrated record of successful regulatory submissions.
• Experience in precision oncology, rare disease, and/or companion diagnostic (CDx) is a plus.
• Experience in interpretation of regulations, guidelines, and policy statements.
• Strong verbal and written communication skills.
• Self-motivated and driven with a proactive and flexible working style.

Nice To Haves

• Advanced degree or education in a scientific field.
• Experience in precision oncology, rare disease, and/or companion diagnostic (CDx).

Responsibilities

• Report to the Head of Regulatory Affairs and work with research and development colleagues to develop and execute innovative regulatory strategies for development programs.
• Lead the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA).
• Communicate with global regulatory authorities and lead the preparation and conduct of meetings with health authorities.
• Integrate knowledge of current legislation, guidelines, and regulatory intelligence into development strategies.
• Proactively identify regulatory opportunities and risks and propose alternative approaches and mitigations.
• Plan and obtain regulatory designations including breakthrough therapy, fast-track, and orphan drug designations.
• Provide oversight to global regulatory activities performed by Clinical Research Organizations (CROs) and regulatory vendors.
• Lead and mentor junior staff in the regulatory team.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees