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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
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
Provide field-based medical support to Sobi’s clinical research programs, registries, and facilitation of the investigator-initiated research process. Communicate key medical insights from KOLs/HCPs to inform refinement of medical strategies or tactics;
The individual will ensure training is relevant, compliant, and tailored to regional and country-specific needs while maintaining alignment with Global Medical Affairs strategies and priorities. This role is key to building consistent, high-quality
This role oversees the External Manufacturing Strategic Sourcing team supporting core Generics sourcing needs and is accountable for delivering consistent, compliant, and effective sourcing and contracting outcomes aligned to established category
Manage a team of Scientists, Senior Research Associates and Research Associates within the EDS Bioconjugation team. This includes performance review, goal setting, implementation of personal development plans and provide timely constructive feedback.