Director / Senior Director, Regulatory Affairs

Location: Hybrid
Therapeutic Area: Oncology
Stage: Late-Stage Clinical Development / Registration

Position Summary

We are seeking an experienced regulatory leader to provide strategic and operational regulatory support across late-stage oncology programs. This individual will play a critical role in shaping global regulatory strategy, leading health authority interactions, and driving major regulatory submissions from development through registration. Depending on experience and scope, the position may be hired at either the Director or Senior Director level. Candidates considered at the Senior Director level should have prior people management experience and a demonstrated ability to lead and develop regulatory professionals.

Key Responsibilities

• Lead global regulatory strategy for clinical-stage and registrational oncology programs.
• Provide regulatory leadership across development, submission, approval, and lifecycle management activities.
• Drive preparation and execution of major regulatory submissions, including NDA, MAA, and other global filings.
• Lead development of briefing documents, regulatory assessments, and health authority interaction materials.
• Partner cross-functionally with Clinical Development, Medical Affairs, Biometrics, CMC, Quality, and Commercial teams.
• Assess regulatory risks, identify submission readiness gaps, and develop mitigation strategies.
• Serve as a primary regulatory representative during interactions with FDA and international health authorities.
• Influence key development decisions and ensure alignment with global regulatory requirements.
• Mentor junior regulatory staff and contribute to the growth of the regulatory organization.
• For Senior Director candidates: provide direct people leadership, coaching, and performance management for regulatory team members.

Qualifications

• BS, MS, PharmD, or PhD in a scientific discipline.
• Director level: approximately 10+ years of regulatory affairs experience.
• Senior Director level: approximately 12-15+ years of regulatory affairs experience with prior direct people management experience.
• Strong experience developing and executing clinical regulatory strategy.
• Experience supporting or leading late-stage, registrational development programs.
• Direct involvement in major regulatory submissions, including NDA and/or BLA filings.
• Experience interacting with FDA and other global health authorities.
• Working knowledge of international regulatory frameworks.
• Demonstrated ability to lead cross-functional teams and influence stakeholders at multiple levels.
• Oncology regulatory experience required.

Ideal Candidate

• Current Director or Senior Director of Regulatory Affairs within a biotech or pharmaceutical company.
• Proven track record supporting late-stage oncology assets approaching registration.
• Experience serving as a primary contact for FDA interactions.
• Able to balance strategic leadership with hands-on execution in a fast-paced biotech environment.
• Senior Director candidates should bring prior direct-report management experience and a history of developing regulatory talent.

Leveling Guidance: Candidates without people-management experience would be considered at the Director level. Candidates with demonstrated leadership of direct reports and broader organizational influence would be considered at the Senior Director level.