Principal Country Approval Specialist (Startup Lead)
Thermo Fisher Scientific · Beijing, China
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Principal Country Approval Specialist role at Thermo Fisher Scientific in Beijing overseeing regulatory submissions and country approvals for clinical trials. Manages preparation and coordination of local regulatory submissions, provides regulatory strategy advice, and serves as primary contact between internal teams and local authorities.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 8+ years of experience in regulatory submissions or equivalent combination of education and related experience
- Excellent knowledge of regional and national country regulatory guidelines and EC regulations
- Strong written and oral communication skills with proficiency in English
- Solid negotiation skills and attention to documentation quality
- Ability to mentor team members and work independently with minimal direction
What you'll be doing
- Prepare, review and coordinate local regulatory submissions aligned with global submission strategy
- Provide regulatory strategy advice to internal clients and serve as primary contact with regulatory authorities
- Coordinate site start-up activities with submission timelines to meet PPD cycle time targets
- Develop country-specific patient information and informed consent documents
- Maintain country study files and regulatory compliance documentation in accordance with SOPs
Privacy & handoff
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