Description

You will drive preparation and execution of global regulatory NDA/MAA filings for late-stage oncology programs, managing end-to-end dossier execution and cross-functional coordination. This role is critical to advancing regulatory strategies and ensuring successful approval applications globally.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields
• Minimum 12 years in pharmaceutical/biotech industry and 8 years in Regulatory Affairs including regulatory strategy
• Proven success in executing global NDA/MAAs (preparation, submission, approval)
• In-depth knowledge of CTD structure and dossier management
• Direct experience in oncology drug development with oversight of global Phase 3 registrational studies

Responsibilities

• Develop strategic filing plans under expedited regulatory pathways
• Lead cross-functional MAA kickoff and maintain integrated filing plan
• Drive or support modular NDA Sub-teams for consistent communication and issue resolution
• Lead Health Authority meetings, interactions, and query responses
• Mentor and develop direct reports