Darum lohnt es sich
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 Skills regulatory strategies biosimilar development submission management global submission strategies regulatory compliance regulatory guidance document preparation data management authority interactions briefing books Soft Skills leadership collaboration coordination communication cross-functional teamwork strategic alignment clear storytelling feedback implementation organizational skills problem-solving #J-18808-Ljbffr 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.
