EU Regulatory Change Leader
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.
The candidate will review SmPCs, labels, manufacturing licences and GMP certificates, providing regulatory intelligence and expert review of CMC documentation as needed.