Description

You will lead US regulatory filing activities for late-stage oncology programs, coordinating cross-functional teams to prepare and submit NDAs. You will develop strategic filing plans, manage Health Authority interactions, and mentor direct reports.

Requirements

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

Responsibilities

• Drive preparation and execution of NDA/MAA filings for oncology programs
• Lead cross-functional NDA kickoff and maintain integrated filing plan
• Identify and mitigate risks to regulatory timelines and outcomes
• Lead Health Authority meetings and query responses
• Mentor and develop direct reports