Ctry Approval Spec
Thermo Fisher Scientific · Beijing, China
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Role summary
Thermo Fisher Scientific seeks a Country Approval Specialist to support clinical trial startup activities in Beijing. The role involves managing and coordinating regulatory submissions, providing local strategy guidance, and ensuring alignment between submission and site activation timelines across clinical research programs.
What they're looking for
- Bachelor's degree or equivalent education
- Knowledge of local regulatory requirements and submission processes
- Familiarity with clinical trial protocols and startup procedures
- Strong organizational and coordination skills
- Ability to maintain accurate trial documentation and databases
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy advice to internal clients regarding Ministry of Health and Ethics Committee requirements
- Serve as key contact for country-level ethical and regulatory submission activities
- Coordinate site startup activities with internal departments to maintain critical path timelines
- Maintain trial status information and country study files according to company standards
Privacy & handoff
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