Senior Level Regulatory Affairs Specialist Jobs

INTRODUCTION

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, is being evaluated in an ongoing Phase 1/2 clinical trial in the U.S. and Europe across multiple solid tumor indications. RPTR-1-201 has received FDA Fast Track designation for advanced triple-negative breast cancer. Repertoire plans to advance additional TCR bispecific therapies into clinical development. 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 Senior Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and senior regulatory leader for its clinical-stage oncology programs. Reporting to the Chief Medical Officer, the Senior Director will own and be accountable for global regulatory strategy and execution from Phase 1/2 development through registrational planning in the U.S., EU, UK, and support activities in Asia-Pacific, partnering closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners. As the primary point of contact for health authorities and a senior regulatory advisor to cross-functional teams and leadership, the Senior Director will provide strategic guidance, hands-on execution, and proactive risk management, translating complex regulatory requirements into clear recommendations for program and company decisions. This is a hands-on leadership 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, build the Regulatory Affairs function, and advance 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 from Phase 1/2 development through registrational planning.
- Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies.
- Ensure regulatory compliance and maintenance of active INDs and CTAs, including annual reports/DSURs, Investigator’s Brochure updates, and expedited safety reporting in partnership with Pharmacovigilance, and maintain inspection readiness.
- Lead and negotiate health authority interactions with FDA, EU regulatory authorities, and MHRA, and other health authorities as programs expand (e.g., Asia-Pacific)—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 expedited programs, designations, and approval pathways (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, PRIME, Accelerated Approval).
- Lead regulatory strategy for oncology-specific requirements, including dose optimization (FDA Project Optimus), pediatric plans (iPSP/PIP and RACE Act molecular-target assessments), and the evidentiary package needed for future registrational trials.
- Serve as the accountable regulatory lead for all components of Repertoire’s development programs, including any associated assays, biomarkers, diagnostics, or devices, as applicable.
- 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 and comparability, IND/IMPD content, product stability, and other issues arising during clinical development.
- Anticipate regulatory risks and opportunities, lead resolution of critical regulatory issues, and develop practical, well-vetted mitigation strategies.
- Monitor evolving U.S., EU, UK, and support activities in Asia-Pacific regulatory requirements and guidance (including FDA guidance on bispecific antibody development programs and oncology dose optimization) 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 and oversee practical regulatory processes, policies, and infrastructure appropriate for a growing clinical-stage biotech.
- Represent Regulatory Affairs on cross-functional program teams and serve as a senior regulatory advisor to the leadership team, providing clear, actionable recommendations on strategic options, risks, and trade-offs.
- Provide regulatory leadership for business development and partnerships, including regulatory due diligence, input into alliance governance, and coordination with partners’ regulatory teams.
- Review regulatory content in investor, public, and SEC disclosures and support regulatory diligence for financings and other corporate transactions.
- Build and scale Repertoire’s Regulatory Affairs function as additional programs enter the clinic, including future team hiring, talent development, and line management.

QUALIFICATIONS/EXPERIENCE

- Bachelor’s degree in a life science required; advanced degree (PhD, PharmD, MD, or MS) strongly preferred. RAC certification a plus.
- 12+ years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development, with demonstrated progression into senior regulatory strategy and leadership roles.
- Strong experience supporting Phase 1 and Phase 2 oncology drug development; experience with T cell engagers, bispecific antibodies, or other immuno-oncology biologics strongly preferred.
- Experience with late-stage development planning, including End-of-Phase 2 meetings, registrational trial design, expedited programs, and Accelerated Approval with confirmatory trials (preferred); BLA/MAA experience a plus.
- Familiarity with regulatory requirements for biomarkers, assays, or in vitro diagnostics used in clinical development (preferred).
- Significant experience with U.S. INDs and direct FDA interactions.
- Strong experience with EU clinical trial submissions and CTIS; UK/MHRA and Asia-Pacific (e.g., PMDA) regulatory experience preferred.
- Proven track record leading and negotiating 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 in a public company environment, including review of regulatory disclosures and support of financing or partnering diligence (preferred).
- Experience managing external regulatory consultants, CROs, or other regulatory service providers, including regulatory operations and eCTD publishing vendors.
- Experience building or scaling a Regulatory Affairs function, including people leadership and talent development (preferred).
- Excellent communication skills and executive presence, with the ability to influence senior leadership and collaborate effectively across teams; highly organized with strong problem-solving, critical thinking, and prioritization skills.

COMPENSATION AND BENEFITS

The base salary for this role ranges from $250,000 to $300,000 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.

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.