Director, Regulatory Affairs - US Filing Lead

Revolution Medicines is seeking a Director of Regulatory Affairs (US Filing Lead) to drive the preparation and execution of regulatory filings for late-stage oncology programs in the US. The role requires a thorough understanding of oncology drug development, US NDA regulations, and current Health Authority thinking, as well as strong leadership and problem-solving abilities.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• Minimum 12 years in the pharmaceutical/biotech industry or relevant work experience
• Minimum 8 years in Regulatory Affairs, including a regulatory strategy role
• Proven success in executing US NDAs (preparation, submission & approval)
• Experience filing applications under expedited filing pathways and programs
• Direct experience in oncology drug development
• Flexibility to support business needs of dynamic registrational programs
• Excellent communication, planning, and organizational skills

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities