Requirements: English
Company: Discover International
Region: Province of Ancona , Marche
Freelance Regulatory Affairs Consultant (0.5 FTE, 12-Month Contract)Locations:Italy, Switzerland, GermanyEngagement:Freelance / Independent ConsultantDuration:12 months (max 0.5 FTE)Start:ASAPKey ResponsibilitiesRegulatory Submissions Maintenance:Prepare, update, and submitlocal (country-level)regulatory documentation (SPC, PIL, abbreviated PI, PSURs, renewals, variations, etc.).Support local Marketing Authorisation Applications (MAAs) and manage post-approval activities.Update and approve local product artworks and country label deviations.Ensure compliance with CCDS and local regulatory requirements.Operational Support:Maintain and update Veeva Vault RIM and local regulatory systems.Handle regulatory fee calculations, payment requests, and Change Control procedures.Provide local regulatory intelligence and support SOP review and updates.