Director of Regulatory Affairs

Job Summary

To support global oncology programs, the contract Director of Regulatory Affairs will serve as the Regulatory Study Lead, developing regulatory strategies, leading health authority interactions, and collaborating with cross-functional teams in a remote capacity.

Key responsibilities

• Develop and implement robust global regulatory strategies for oncology programs
• Lead health authority interactions and ensure regulatory needs are met for late-stage programs
• Mentor direct reports and represent Regulatory Affairs at the senior leadership level

Required 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
• Direct experience in oncology drug development, including oversight of large global Phase 3 studies
• Demonstrated success in leading health authority interactions and negotiations
• Global clinical trials experience required; NDA experience strongly preferred