Global Regulatory Lead, Oncology Trials (Phase 1–2)

Repertoire Immune Medicines, Inc.; Northern (KY); Hybrid; USD 210,000 - 245,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) retirement plan

Short/Long-term incentives

Job summary

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.

Qualifications

• 10+ years of Regulatory Affairs experience in biotechnology or pharma drug development.
• Proven track record leading Phase 1/2 oncology regulatory programs.
• Experience with U.S. INDs, FDA interactions, and EU CTIS/CTIS processes.
• Experience with UK/MHRA regulatory activities and cross‑functional teams.

Responsibilities

• Serve as internal Regulatory Lead for oncology programs, defining global strategy for Phase 1 and 2.
• Lead IND/CTA submissions and amendments, coordinating with FDA, EU authorities, and MHRA.
• Provide strategic regulatory guidance for early development and potential expedited pathways.
• Collaborate with Clinical Development, CMC, Quality to embed regulatory considerations.
• Identify regulatory risks and develop practical mitigation strategies.
• Oversee external regulatory consultants and vendors to build in‑house expertise.
• Represent Regulatory Affairs on cross‑functional teams and advise senior leadership.

Skills

Regulatory strategy

Regulatory leadership

Cross-functional collaboration

Regulatory submissions

Regulatory risk management

Communication

Project management

Job description

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.