FSP Country Approval Specialist (all level)
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, site contracts, and country-level approval activities for clinical trials. The role involves coordinating submissions with regulatory authorities, negotiating site agreements, and ensuring timely study activation in alignment with global strategy.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 3–5 years of clinical trial start-up, country approval, site activation, or regulatory affairs experience
- Demonstrated experience independently managing site contract and budget negotiations
- Strong knowledge of clinical trial agreements, site budgets, and negotiation strategies
- Excellent oral, written, and interpersonal communication skills
- Proficiency in Microsoft Office and clinical trial management systems
- Knowledge of regional/national regulatory guidelines and EC regulations
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions (HSA, EC, and special applications) aligned with global strategy
- Manage site contract and budget negotiations with investigative sites and institutions independently
- Serve as primary contact for investigators and local regulatory authorities on submission-related matters
- Develop country-specific Patient Information Sheets and Informed Consent Form documents
- Oversee country study files, maintain trial status information, and identify regulatory risks or anomalies
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.