Regulatory Affairs Project Manager

12 month, 100% remote, Full time

Max 55 EUR/hour

The Project Manager will collaborate closely with the RA Manager EU and the Client’s Leadership Team to coordinate workload and prioritisation for regulatory consultants. Core responsibilities include:

• Regulatory Labeling & Artwork Management:
• Creating and updating country label deviations, national SmPCs/PILs, CCDS compliance checks, preparing local abbreviated PI, supporting annex translations for centralised products, and updating/approving local artworks.
• Regulatory Submission Activities:
• Preparing and submitting national variations, renewals, PSURs, RTQs, MAAs, and MRP/DCP documentation (including via Veeva Vault RIM and non-CESP routes); updating submission records and approval dates.
• Local Regulatory Support & Intelligence:
• Providing in-country regulator...