Requirements: English
Company: Discover International
Region: Asti , Piedmont
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.