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Contract Director, Regulatory Affairs
Key Responsibilities
- Serve as the Regulatory Study Lead for global oncology programs, providing clear and actionable regulatory strategy across assigned programs
- Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and alignment with corporate goals
- Lead and support health authority interactions and negotiations
- Ensure late-stage oncology programs are fully resourced and that regulatory needs are anticipated to deliver on programming milestones
- Drive consistency in regulatory approach across programs, ensuring lessons learned are applied broadly
- Collaborate with management colleagues across Clinical Research, Clinical Operations, Medical Writing, Quality, and other functions to ensure cross-functional alignment
- Mentor and develop direct reports to support team performance and growth
- Represent Regulatory Affairs at the senior leadership level and on cross-functional teams
- Support policy and process development within Regulatory Affairs and cross-functionally
Qualifications
- Degree in life sciences, pharmacy, medicine, or a related field
- Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in regulatory affairs including strategy and leadership roles
- Direct experience in oncology drug development, including oversight of large global Phase 3 and platform studies
- Demonstrated success leading health authority interactions and negotiations
- NDA experience strongly preferred
- Global clinical trials experience required; candidates whose regulatory experience is exclusively in CMC, diagnostics, or a combination of the two will not be considered
- Strong track record in alliance management and coordination with external development or commercialization partners
- Advanced degree desirable