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Contract – Director, Regulatory Science
Key Responsibilities
- Develop and deliver regulatory strategy across drug development programs, ensuring alignment with company goals and competitive landscape
- Ensure consistent regulatory advice and decision-making across programs, incorporating learnings from one program into all others
- Anticipate upcoming regulatory needs and ensure programs are fully resourced for applicable stages of development
- Lead and mentor direct reports, supporting professional development and performance
- Establish cross-functional partnerships with Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality, and other functions to drive alignment and team effectiveness
- Integrate expert feedback and competitive intelligence into regulatory strategy
Qualifications
- Degree in life sciences, pharmacy, medicine, or related field; advanced degree preferred
- Minimum 12 years in pharmaceutical/biotech industry; minimum 8 years in Regulatory Affairs including strategy and leadership roles
- Demonstrated success leading global regulatory submissions
- Direct experience in oncology drug development
- Experience with combination studies, multiple expansion cohort, basket/umbrella, or master protocols preferred
- Prior NDA experience preferred
- Strong cross-functional collaboration and senior leadership communication skills
- Ability to manage multiple programs simultaneously under tight timelines