EU Regulatory Change Leader - CMC & RA Expert

16 ott - Roma
Thermofisher Scientific

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.

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