Director, Regulatory Affairs

Company Overview

Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune system to develop transformative therapies for cancer and autoimmune disease. Using its proprietary DECODE™ platform—which maps the immune synapse between T cell receptors (TCRs) and their antigen targets—Repertoire translates unique biological insights into potent and targeted off-the-shelf immune medicines. The company integrates deep protein engineering expertise with artificial intelligence, powered by a proprietary DECODE database of over one billion TCR-antigen interactions, to accelerate discovery and optimize drug candidates.

From its sites in Watertown, Massachusetts and Zurich, Switzerland, Repertoire is advancing a pipeline of T cell-targeted immunotherapies with the potential to address a broad range of cancers and autoimmune disorders. The company’s lead oncology program, RPTR-1-201, a TCR bispecific, has initiated a Phase 1/2 clinical trial across multiple solid tumor indications. Repertoire plans to advance additional TCR bispecific therapies into clinical trials over the next 12-18 months.

In autoimmune disease, Repertoire is partnering with leading pharmaceutical companies to develop mRNA tolerizing therapies designed to selectively expand regulatory T cells and reset the immune system.

Repertoire was founded in 2019 by Flagship Pioneering and is supported by a strong investor base. The DECODE platform has been validated through four strategic partnerships with leading pharmaceutical companies—Bristol Myers Squibb, Genentech, Eli Lilly, and Pfizer—representing over $4.5 billion in disclosed total deal value and $185 million in upfront payments received to date.

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.

• 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…