Regulatory Affairs Consultant

Providing freelance & interim solutions to Biotech & Pharma 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 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

Location: it, IT

Posted Date: 6/16/2025