Director, Regulatory Affairs (US Filing Lead)

Revolution Medicines is seeking a Director, Regulatory Affairs (US Filing Lead) to drive preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• 12 years in the pharmaceutical/biotech industry or relevant work experience
• 8 years in Regulatory Affairs including a regulatory strategy role
• Proven success in executing US NDAs
• Experience filing applications under expedited filing pathways and programs
• Demonstrated ability to lead Health Authority interactions and negotiations
• In-depth knowledge of CTD structure and management of dossier components
• Direct experience in oncology drug development

Benefits

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