Director, Regulatory Affairs

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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

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