Requirements: English
Company: JR Italy
Region: Cremona , Lombardia
Social network you want to login/join with: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 submit local (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.#J-18808-Ljbffr