Senior Country Approval Specialist
Thermo Fisher Scientific · Remote
RegulatoryRemoteFull timeCompany career page
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Role summary
Thermo Fisher Scientific seeks a Senior Country Approval Specialist to manage regulatory submissions and coordinate approval processes across countries. The role involves developing submission strategies, liaising with regulatory authorities, and ensuring timely site activation in alignment with global submission plans.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 5+ years of experience in regulatory affairs or related field
- Excellent written and oral communication skills
- Strong knowledge of regional and national regulatory guidelines
- Proficiency with computer systems and ability to learn regulatory software
- Basic medical terminology and therapeutic area knowledge
- Ability to work independently and mentor team members
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy advice to internal stakeholders and serve as primary authority contact
- Develop and implement local submission strategies with technical oversight and departmental coordination
- Oversee country study files and ensure compliance with company and client standard operating procedures
- Coordinate feasibility activities and site start-up timelines to meet critical path requirements
Privacy & handoff
This role links to Thermo Fisher Scientific's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.