Senior/Principal - Country Approval Specialist

Thermo Fisher Scientific • NC, US • published 2026-09-20 10:54:43.365819

Description

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Join Us as a Senior/Principal Country Approval Specialist \- Make an Impact at the Forefront of Innovation The Senior/Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. **What You'll Do:** * Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. * Provide local regulatory strategy advice (MoH \&/or EC) to internal clients. * Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments. * Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner. * Ensure guidelines and processes are followed for effective internal team communications as well as commun...

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