Requirements: English
Company: Discover International
Region: Ravenna , Emilia-Romagna
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