Description

You will lead cross-functional regulatory submission activities for late-stage oncology programs, driving NDA/MAA filings and ensuring effective coordination across clinical, CMC, quality, and commercial teams. Your work will directly support expedited regulatory approvals for novel RAS-targeted therapies.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• Minimum 12 years in pharma/biotech with 8 years in Regulatory Affairs including regulatory strategy
• Proven success in executing US NDAs
• Direct experience in oncology drug development including Phase 3 registrational studies
• In-depth knowledge of CTD structure and dossier components

Responsibilities

• Drive preparation and execution of US NDA/MAA filings for late-stage oncology programs
• Manage end-to-end dossier execution with cross-functional coordination
• Develop strategic filing plans under expedited regulatory pathways
• Lead Health Authority meetings, interactions, and query responses
• Motivate, mentor, and develop direct reports