Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease. Backed by SoftBank VF.
About the role
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.
What they're looking for
- 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
- 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
More about this role
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...
Read the full posting on Repertoire Immune Medicines's site ↗
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