Country Approval Specialist
Thermo Fisher Scientific · Athens, Greece
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Role summary
Thermo Fisher Scientific seeks a Country Approval Specialist in Athens to manage and coordinate local regulatory submissions for clinical trials across multiple countries. The role involves preparing submissions to health authorities, providing regulatory strategy advice, and ensuring alignment with global submission timelines and compliance requirements.
What they're looking for
- Bachelor's degree or equivalent formal qualification in relevant field
- 2+ years of experience in regulatory affairs or clinical trial management
- Strong written and oral communication skills in English
- Knowledge of regional and national regulatory guidelines and EC regulations
- Proficiency with computer systems and ability to learn specialized software
- Medical terminology and therapeutic area knowledge
- Excellent attention to detail and documentation quality
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions to health authorities and ethics committees
- Provide regulatory strategy guidance aligned with global submission strategy
- Coordinate submission-related activities with internal departments and investigators
- Maintain and update trial status information in tracking databases accurately
- Establish and maintain country-level study files according to standard operating procedures
Privacy & handoff
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