Senior Director, Regulatory Affairs

Repertoire Immune Medicines•Watertown, MA

2d•Onsite

About The Position

Repertoire Immune Medicines is seeking its first internal Regulatory Affairs hire and senior regulatory leader for its clinical-stage oncology programs. Reporting to the Chief Medical Officer, this hands-on leadership role owns global regulatory strategy and execution from Phase 1/2 development through registrational planning in the U.S., EU, and UK, with support activities in Asia-Pacific. The role serves as the primary point of contact for health authorities and a senior regulatory advisor to cross-functional teams and company leadership, providing strategic guidance, hands-on execution, and proactive risk management. It is based in Watertown, Massachusetts, with in-office presence at least three days per week in a fast-paced, collaborative environment. The Senior Director will help shape Repertoire’s regulatory strategy, build the Regulatory Affairs function, and advance its therapies.

Requirements

Bachelor’s degree in a life science is required.
12 or more years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development, with progression into senior regulatory strategy and leadership roles.
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.
Proven track record leading and negotiating health authority interactions, including 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 regulatory service providers, including regulatory operations and eCTD publishing vendors.
Excellent communication skills and executive presence, with the ability to influence senior leadership and collaborate effectively across teams.
Strong organization, problem-solving, critical-thinking, and prioritization skills.

Nice To Haves

Advanced degree (PhD, PharmD, MD, or MS).
RAC certification.
Experience with T cell engagers, bispecific antibodies, or other immuno-oncology biologics.
Experience with late-stage development planning, including End-of-Phase 2 meetings, registrational trial design, expedited programs, and Accelerated Approval with confirmatory trials.
BLA/MAA experience.
Familiarity with regulatory requirements for biomarkers, assays, or in vitro diagnostics used in clinical development.
UK/MHRA and Asia-Pacific (e.g., PMDA) regulatory experience.
Experience in a small or mid-sized biotechnology environment.
Experience in a public company environment, including regulatory disclosure review and financing or partnering diligence.
Experience building or scaling a Regulatory Affairs function, including people leadership and talent development.

Responsibilities

Serve as the internal Regulatory Lead for clinical-stage oncology programs and develop and execute global regulatory strategy from Phase 1/2 through registrational planning.
Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies.
Ensure compliance and maintenance of active INDs and CTAs, including annual reports/DSURs, Investigator’s Brochure updates, expedited safety reporting with Pharmacovigilance, and inspection readiness.
Lead and negotiate health authority interactions with FDA, EU authorities, MHRA, and other authorities as programs expand, including strategy, briefing materials, meeting preparation, and agency correspondence.
Guide early clinical development, including Phase 1 positioning for Phase 2, expedited programs, designations, and approval pathways such as Fast Track, Breakthrough Therapy, Orphan Drug, PRIME, and Accelerated Approval.
Lead oncology regulatory strategy for dose optimization, pediatric plans (iPSP/PIP and RACE Act molecular-target assessments), and evidence packages for future registrational trials.
Serve as accountable regulatory lead for development-program components, including associated assays, biomarkers, diagnostics, or devices, as applicable.
Partner with Clinical Development, Clinical Operations, CMC, and Quality to incorporate 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 clinical-development issues.
Anticipate regulatory risks and opportunities, resolve critical regulatory issues, and develop practical mitigation strategies.
Monitor evolving U.S., EU, UK, and Asia-Pacific regulatory requirements and guidance and translate implications for development programs.
Manage and direct external regulatory consultants and vendors while developing in-house regulatory expertise and ownership.
Establish and oversee practical regulatory processes, policies, and infrastructure for a growing clinical-stage biotech.
Represent Regulatory Affairs on cross-functional program teams and advise leadership with actionable recommendations on strategic options, risks, and trade-offs.
Provide regulatory leadership for business development and partnerships, including due diligence, alliance governance input, and coordination with partner regulatory teams.
Review regulatory content in investor, public, and SEC disclosures and support regulatory diligence for financings and corporate transactions.
Build and scale the Regulatory Affairs function as programs enter the clinic, including future hiring, talent development, and line management.