CMC Specialist (m/k)

CMC Specialist (m/k) Miejsce pracy: Warszawa Your responsibilities Prepare or support the preparation, authoring, and updating the quality (CMC) sections of regulatory dossiers, including CTD Module 2.3 and Module 3 and technical file, for marketing authorization applications and lifecycle submissions. Prepare or support the preparation, update, and maintenance of CMC documentation for: - Initial marketing authorization applications - Post‑approval changes (variations) - Product lifecycle manag…