Description

You will lead global NDA/MAA filings for late-stage oncology programs at a clinical-stage biotech, coordinating cross-functional teams and regulatory strategies to accelerate drug approvals. This high-impact role involves developing filing plans, managing dossier execution, and interacting with health authorities.

Requirements

• Degree in life sciences, pharmacy, medicine, or related field
• 12+ years in pharma/biotech with 8+ years in Regulatory Affairs including regulatory strategy
• Proven success in executing global NDA/MAAs
• Experience with expedited filing pathways and Health Authority interactions
• In-depth knowledge of CTD structure and oncology drug development

Responsibilities

• Lead preparation and execution of global regulatory NDA/MAA filings
• Coordinate cross-functional teams across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine, and Commercial
• Develop strategic filing plans under expedited regulatory pathways
• Manage dossier filing, sub-team rosters, and integrated filing timelines
• Drive Health Authority meeting preparations, interactions, and query responses