Country Approval Specialist - FSP - EMEA
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About the Role
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Join Us as a Country Approval Specialist Make an Impact at the Forefront of Innovation We have successfully supp.
Key Skills for This Role
Responsibilities
- Prepare, review, and coordinate local regulatory submissions (MoH, EC) in alignment with global submission strategy.
- Provide local regulatory strategy advice to internal clients.
- Coordinate with internal departments to align site start up activities with submission timelines.
- Maintain trial status information in tracking databases.
Requirements
- Experience in regulatory submissions or clinical trial start up
- Knowledge of local regulatory guidelines and SOPs
- Strong organizational and coordination skills
Full Job Posting
Overview
- Join Thermo Fisher Scientific as a Country Approval Specialist in the FSP team, supporting clinical trials across EMEA.
- You will manage and coordinate country submissions for regulatory and ethical approvals.
What You'll Do
- Prepares, reviews and coordinates local regulatory submissions (MoH, EC, special applications) under guidance.
- Provides local regulatory strategy advice to internal clients.
- Coordinates with internal departments to align site start up activities with submission timelines.
- Maintains trial status information in PPD tracking databases.
- Ensures local study files are prepared and maintained per SOPs.
Qualifications
- Experience in regulatory submissions or clinical trial start up.
- Knowledge of regulatory guidelines and SOPs.
- Strong organizational and communication skills.
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