Requirements: English
Company: Discover International
Region: Treviso , Veneto
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 Authorization 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.Additional Information: Regulatory Consultant Treviso, Veneto, Italia#J-18808-Ljbffr