Director, Regulatory Affairs - Global Filing Lead

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company is seeking a Director of Regulatory Affairs (Global Filing Lead) to drive preparation and execution of global regulatory NDA/MAA filings for late-stage oncology programs.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• Minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience
• Minimum of 8 years in Regulatory Affairs including a regulatory strategy role
• Proven success in executing global NDA/MAAs (preparation, submission & approval)
• 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 including oversight of large, global Phase 3 registrational studies

Benefits

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