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. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a 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 to enable fastest possible regulatory approval.
• 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.
• Flexibility to support business needs of dynamic registrational programs.
• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

Benefits

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