Senior Director, Regulatory Affairs

Repertoire Immune Medicines•Watertown, MA

1d•$250,000 - $300,000•Onsite

About The Position

Repertoire Immune Medicines is seeking an experienced Senior Director of Regulatory Affairs to serve as 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 leader will own 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 will serve as the primary health-authority contact and a senior regulatory advisor to cross-functional teams and company leadership, providing strategic guidance, hands-on execution, and proactive risk management. The Senior Director will lead regulatory strategy and submissions, support clinical and registrational development planning, manage agency interactions, and ensure compliance and inspection readiness. The role partners closely with Clinical Development, Clinical Operations, CMC, Quality, Pharmacovigilance, external regulatory partners, and business partners. It also establishes practical regulatory processes and infrastructure, directs external consultants and vendors, and builds and scales the Regulatory Affairs function as programs advance. The position is based in Watertown, Massachusetts, and requires in-office presence at least three days per week. It offers the opportunity to shape the company’s regulatory strategy and advance its therapies in a fast-paced, collaborative environment. The base salary range is $250,000 to $300,000, with medical, dental, vision, and life insurance, flexible time off, a 401(k) plan, and short- and long-term incentive opportunities.

Requirements

Bachelor’s degree in a life science field.
At least 12 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.
Experience 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 across teams.
Strong organization, problem-solving, critical-thinking, and prioritization skills.

Nice To Haves

Advanced degree (PhD, PharmD, MD, or MS); strongly preferred.
RAC certification.
Experience with T cell engagers, bispecific antibodies, or other immuno-oncology biologics.
Late-stage development planning experience, 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.
EU clinical trial submission and CTIS experience; 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 clinical studies.
Maintain 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 the FDA, EU authorities, MHRA, and other authorities as programs expand, including strategy, briefing materials, meeting preparation, and agency correspondence.
Advise on early clinical development, Phase 2 positioning, expedited programs, designations, and approval pathways.
Lead oncology regulatory strategy for dose optimization, pediatric plans, and the evidence package for future registrational trials.
Serve as accountable regulatory lead for development-program components, including applicable assays, biomarkers, diagnostics, and devices.
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 issues, and develop mitigation strategies.
Monitor regulatory requirements and guidance in the U.S., EU, UK, and Asia-Pacific and explain implications for development programs.
Manage external regulatory consultants and vendors while building in-house regulatory expertise and ownership.
Establish and oversee regulatory processes, policies, and infrastructure for a growing clinical-stage biotechnology company.
Represent Regulatory Affairs on cross-functional teams and advise leadership 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, including future hiring, talent development, and line management.