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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;
Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader; Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process; Assures and exerts
In this role you will be responsible for ensuring strategies and relationships with local authorities align with the business needs of Perrigo Europe North Cluster with a particular focus on UK & Ireland. Ensure company’s regulatory affairs