Director, Global Regulatory Affairs Lead

Full-time Management & Operations

Responsibilities

• Shape and drive regulatory strategies for biosimilar development and lifecycle management
• Coordinate cross-functional activities for high-quality submissions
• Lead interactions with health authorities and ensure effective implementation of feedback

Requirements

• Global regulatory leadership for biosimilar development
• Management of submission-related documents and data
• Preparation and execution of meetings with Health Authorities (e.g. EMA, FDA)
• Development of global submission strategies for biosimilar dossiers
• Compliance with regulatory requirements across key markets (EU, US, Canada, Switzerland, Brazil)
• Alignment and endorsement of regulatory strategies with Development Team and Biosimilar Management Team (BMT)
• Delivery of clear regulatory storylines for authority interactions (e.g. briefing books, submissions)
• Collaboration w...