Director, Global Regulatory Affairs — Oncology

EPM Scientific; Jersey City (NJ); Hybrid; USD 180,000 - 260,000; Full time

Job summary

EPM Scientific seeks a Director/Senior Director of Regulatory Affairs to lead global regulatory strategy for late-stage oncology programs, shaping interactions with health authorities and driving major submissions from development through registration.

The role requires expertise in NDA/MAA filings, cross-functional leadership, and the ability to mentor a growing regulatory team in a fast-paced biotech environment based in the United States.

Qualifications

• Regulatory strategy development and execution.
• Experience leading interactions with FDA and other health authorities.
• Ability to lead cross-functional teams across development, QA, CMC, Medical Affairs.
• Mentor and develop regulatory staff across levels.
• Oncology regulatory affairs experience is required.

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 (NDA/MAA and global filings).
• Develop briefing documents, regulatory assessments, and health authority interaction materials.
• Partner with Clinical Development, Medical Affairs, Biometrics, CMC, Quality, and Commercial teams.

Skills

Regulatory strategy

FDA interactions

Cross-functional leadership

People management

Oncology regulatory affairs

Education

BS/MS/PharmD/PhD in scientific discipline

Job description

EPM Scientific seeks a Director/Senior Director of Regulatory Affairs to lead global regulatory strategy for late-stage oncology programs, shaping interactions with health authorities and driving major submissions from development through registration.

The role requires expertise in NDA/MAA filings, cross-functional leadership, and the ability to mentor a growing regulatory team in a fast-paced biotech environment based in the United States.