Director, Regulatory Affairs

Repertoire Immune Medicines•Watertown, MA

3d•$210,000 - $245,000•Hybrid

About The Position

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.

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.
Experience managing external regulatory consultants, CROs, or other regulatory service providers.
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).

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.