Director of Regulatory Affairs

Job Summary

Providing regulatory leadership for U.S. promotional and commercial communications, the full-time Director of Regulatory Affairs will manage the Promotional Review Committee, oversee regulatory submissions, and collaborate cross-functionally to ensure compliant and effective communications for RayzeBio products in a remote setting.

Key responsibilities

• Lead the regulatory assessment and submission of promotional materials to the FDA, ensuring compliance with established standards
• Participate in Promotional Review Committee meetings, providing regulatory insights and resolving compliance-related issues
• Advise cross-functional teams on regulatory requirements throughout the material lifecycle, from concept development to launch readiness

Required qualifications

• Bachelor's degree or higher in life sciences, pharmacy, health sciences, or a related field; advanced degrees preferred
• Approximately 8+ years of experience in pharmaceutical or biotechnology Regulatory Affairs, particularly in advertising and promotion review
• Demonstrated experience as a Regulatory Reviewer in promotional review processes
• Strong knowledge of FDA advertising and promotion requirements and relevant guidance
• Experience with product launch and lifecycle communications, preferably in oncology or radiopharmaceuticals