Regulatory Affairs Consultant

Freelance Regulatory Affairs Consultant (0.5 FTE, 12-Month Contract) Locations: Italy, Switzerland, Germany Engagement: Freelance / Independent Consultant Duration: 12 months (max 0.5 FTE) Start: ASAP Key Responsibilities Regulatory 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

Location: treviso, IT

Posted Date: 6/15/2025