Ctry Approval Spec
Thermo Fisher Scientific · Beijing, China
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Role summary
Thermo Fisher Scientific seeks a Country Approval Specialist in Beijing to support clinical trial startup activities. The role involves managing and coordinating regulatory submissions, providing local regulatory strategy guidance, and ensuring alignment between submission and site activation timelines.
What they're looking for
- Bachelor's degree or equivalent formal academic or vocational qualification
- Knowledge of local regulatory submission processes and requirements
- Understanding of clinical trial regulatory guidelines and company SOPs
- Ability to coordinate with internal departments and external stakeholders
- Attention to detail and ability to maintain accurate trial documentation
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy advice to internal clients on country-specific requirements
- Serve as key contact for ethical and regulatory submission-related activities
- Coordinate site startup activities with internal departments to meet critical path timelines
- Maintain trial status information and country study files in tracking databases
Privacy & handoff
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