Director, Regulatory Affairs

Repertoire Immune Medicines; Watertown (MA); On-site; USD 210,000 - 245,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible time off

401(k) retirement plan

Short-term incentive opportunities

Long-term incentive opportunities

Job summary

Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week.

The role will own INDs/CTAs, health authority interactions (FDA, EU, MHRA), and provide strategic guidance while partnering with Clinical Development, CMC, and Quality to advance innovative therapies for patients.

Qualifications

• 10+ years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development with leadership responsibilities.
• Experience leading Phase 1/2 oncology programs and IND/CTA submissions.
• Experience with US FDA interactions and EU regulatory submissions (CTIS) and UK/MHRA preferred.
• Ability to lead health authority interactions and prepare briefing materials and correspondence.
• Collaboration with Clinical Development, CMC, Quality, and external regulatory partners.
• Experience managing external regulatory consultants or CROs.
• Knowledge of CMC considerations in early clinical development.

Responsibilities

• Serve as internal Regulatory Lead for clinical-stage oncology programs, executing global regulatory strategy.
• Lead submissions for INDs, CTAs, amendments, and related documents.
• Manage health authority interactions with FDA, EU regulators, and MHRA.
• Provide strategic regulatory guidance on early development and potential expedited pathways.
• Partner with cross-functional teams to embed regulatory strategy into development plans.
• Advise on protocols, development plans, CMC changes, and regulatory content.
• Identify regulatory risks and develop practical mitigations.
• Monitor evolving regulatory requirements and communicate implications.
• Direct external regulatory consultants and vendors, building in-house expertise.
• Establish scalable regulatory processes for a growing biotech.
• Represent Regulatory Affairs in cross-functional programs and leadership briefings.
• Help scale the regulatory function as programs advance into clinic.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Communication

Job description

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.

Role Overview

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.

Key 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.

Qualifications / Experience

• 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 operating in a small or mid-sized biotechnology environment (preferred).
• 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.

The base salary for this role ranges from $210,000 to $245,000 and is determined based on a candidate’s skills, experience, and internal equity. In addition to a competitive base salary, Repertoire offers a broad range of benefits designed to attract, retain, and motivate top talent, including medical, dental, vision, and life insurance, flexible time off, a 401(k) retirement plan, and short- and long-term incentive opportunities. Compensation and benefits are based on Repertoire’s good faith estimate at the time of publication and may be updated in the future.

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Flexible time off
• A 401(k) retirement plan
• Short-term incentive opportunities
• Long-term incentive opportunities

Repertoire is committed to social responsibility and to developing an inclusive culture. Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce. We believe in actively pursuing equity in all facets of the work experience at Repertoire. We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.

Recruitment & Staffing Agencies

Repertoire Immune Medicines ("Repertoire") does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.