Country Approval Specialist - FSP dedicated - EMEA at Thermo Fisher Scientific

The Country Approval Specialist will prepare, review, and coordinate local regulatory submissions, including MoH and EC applications, and provide local regulatory strategy advice. They will manage project-specific local SIA services, liaise with investigators for submission activities, and coordinate with internal departments to align site start-up with submission timelines. Responsibilities also include ensuring alignment with the critical path for site activation, maintaining trial status information, and managing local country study files according to PPD WPDs or client SOPs. The specialist will also maintain knowledge of PPD SOPs, client SOPs/directives, and current regulatory guidelines.