Director, Regulatory Affairs

Repertoire Immune Medicines•Watertown, MA

2d•Hybrid

About The Position

Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and regulatory lead for its clinical-stage oncology programs. The Director will own global regulatory strategy and execution across Phase 1 and Phase 2 development in the U.S., EU, and UK, partnering closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners. As the primary point of contact for health authorities and cross-functional teams, the Director will provide strategic guidance, hands-on execution, and proactive risk management. This is a hands-on role based in Watertown, MA, requiring in-office presence at least 3 days per week, in a fast-paced, collaborative environment offering the opportunity to directly shape Repertoire’s regulatory strategy and the advancement of innovative therapies for patients.

Requirements

10+ years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development, with demonstrated progression into regulatory strategy and leadership responsibilities.
Strong experience supporting Phase 1 and Phase 2 oncology drug development.
Significant experience with U.S. INDs and direct FDA interactions.
Strong experience with EU clinical trial submissions and CTIS; UK/MHRA regulatory experience preferred.
Demonstrated ability to lead health authority interactions, including preparation of briefing materials, meeting strategy, and regulatory correspondence.
Experience working cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality.
Working knowledge of CMC regulatory considerations during early clinical development.
Excellent communication skills, with the ability to collaborate effectively across teams; highly organized with strong problem-solving, critical thinking, and prioritization skills.

Nice To Haves

Experience operating in a small or mid-sized biotechnology environment (preferred).
Experience managing external regulatory consultants, CROs, or other regulatory service providers.

Responsibilities

Serve as the internal Regulatory Lead for Repertoire's clinical-stage oncology programs, developing and executing global regulatory strategy across Phase 1 and Phase 2 development.
Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies.
Lead health authority interactions with FDA, EU regulatory authorities, and MHRA—including strategy development, briefing materials, meeting preparation, and agency correspondence.
Provide strategic regulatory guidance on early clinical development, including positioning Phase 1 programs for successful Phase 2 development and potential expedited or accelerated pathways (e.g., Fast Track, Breakthrough Therapy).
Partner cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality to embed regulatory strategy into development plans and program decisions.
Advise on clinical protocols, development plans, CMC changes, IND/IMPD content, product stability, and other issues arising during early clinical development.
Proactively identify regulatory risks and opportunities and develop practical, well-vetted strategies to address them.
Monitor evolving U.S., EU, and UK regulatory requirements and translate the implications for Repertoire's development programs.
Manage and direct external regulatory consultants and vendors while building regulatory expertise and ownership in-house.
Establish practical regulatory processes and infrastructure appropriate for a growing clinical-stage biotech.
Represent Regulatory Affairs on cross-functional program teams and provide clear, actionable recommendations to senior leadership.
Help build and scale Repertoire's Regulatory Affairs function as additional programs enter the clinic.