Senior Country Approval Specialist
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
Senior Country Approval Specialist manages preparation, review, and coordination of regulatory submissions aligned with global strategy. The role involves serving as primary contact with local regulatory authorities and internal stakeholders to ensure timely submission and site activation across clinical trial projects.
What they're looking for
- Bachelor's degree or equivalent relevant academic/vocational qualification
- 5+ years of experience in regulatory affairs or related field
- Excellent written and oral communication skills in English
- Strong knowledge of regional and national regulatory guidelines and procedures
- Demonstrated ability to manage multiple projects and priorities independently
- Experience with clinical trial regulatory submissions and processes
- Proficiency with computer systems and ability to learn regulatory software
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions in alignment with global submission strategy
- Provide regulatory strategy advice to internal stakeholders and serve as primary contact with local authorities
- Develop and implement country-specific submission strategies with technical oversight and coordination
- Manage regulatory compliance documentation, patient information sheets, and informed consent forms
- Ensure trial status information is accurately maintained in databases and coordinate site activation timelines
Privacy & handoff
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