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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
Lead strategy and execution of Translational Medicine and Quantitative Pharmacology programs supporting in-licensing, global R&D projects, and product registration; Manage and mentor a Quantitative Pharmacology team in Germany focused on dose and regimen
The role will provide scientific and technical leadership for analytical development at various stages of drug development both internal and external through CDMO with particular emphasis on research and early development (pre-DP0) including material