Description

As the Director of Regulatory Affairs, you will define and execute global regulatory strategies for oncology programs. You will lead health authority interactions, mentor a team, and ensure cross-functional alignment to advance novel RAS-targeted therapies. This role is pivotal in driving regulatory success and patient impact.

Requirements

• Degree in life sciences, pharmacy, medicine or related fields
• Minimum 15 years in pharma/biotech with 8+ years in Regulatory Affairs strategy roles
• Proven success in global regulatory strategies and submissions
• Direct experience in oncology drug development including global Phase 3 studies
• Strong track record in alliance management and cross-functional collaboration

Responsibilities

• Provide regulatory strategy as Regulatory Study Lead for global oncology programs
• Motivate, mentor, and develop direct reports
• Ensure late-stage programs are resourced and anticipate regulatory needs
• Develop robust global regulatory strategies aligned with corporate goals
• Drive consistency in regulatory approach and apply lessons learned across programs