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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.
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