Director, Global Regulatory Affairs Lead

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 with Regulatory Operations to implement technologies Provide regulatory guidance to Market Units Leadership of the Regulatory Sub-team Hard Skill...

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