Country Approval Specialist - FSP
Thermo Fisher Scientific · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Country Approval Specialist to manage regulatory submissions and coordinate clinical trial approvals across multiple countries. The role involves preparing local regulatory dossiers, providing strategic guidance, and ensuring submissions align with global timelines and compliance standards.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 2+ years of relevant experience in regulatory affairs or clinical operations
- Strong written and oral communication skills in English
- Knowledge of regional and national regulatory guidelines
- Attention to detail and quality documentation practices
- Proficiency with computer systems and ability to learn specialized software
- Basic medical/therapeutic terminology knowledge
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy guidance to internal clients at country level
- Coordinate submission activities with internal departments and site start-up teams
- Maintain trial status information and regulatory compliance documentation in tracking databases
- Support feasibility activities and may assist with informed consent form development
Privacy & handoff
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