Regulatory Affairs Director – Oncology, Global Strategy Lead

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

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.