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Lead EU pre‑approval regulatory strategy and documentation requirements. Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery. Act as primary liaison with EU Regulatory Authorities; coordinate responses
Lead and actively manage the Analytical Characterization department within Biosimilar technical development of Sandoz and drive a culture of exceptional performance and continuous improvement, enabling innovative, competitive
The role is responsible for leading and developing the medical team, driving innovation, ensuring scientific excellence, regulatory compliance, and strong cross‑functional collaboration to support pre‑ and post‑launch activities across the