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 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.