Thermo Fisher Scientific seeks an experienced Regulatory Affairs professional to support EU/EEA regulatory assessments of changes for clinical trial documentation and related CMC activities. The role focuses on coordinating regulatory change control, SoC preparation and interaction with cross-functional teams.
The candidate will review SmPCs, labels, manufacturing licences and GMP certificates, providing regulatory intelligence and expert review of CMC documentation as needed.
📌 EU Regulatory Change Leader (Roma)
🏢 Thermofisher Scientific
📍 Roma
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