Country Approval Specialist - FSP - Portugal
Thermo Fisher Scientific · Lisbon, Portugal
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 and coordinate local regulatory submissions for clinical trials across multiple countries. This role involves preparing submissions, advising on regulatory strategy, and ensuring alignment with global submission timelines in an office-based position in Lisbon.
What they're looking for
- Bachelor's degree or equivalent formal academic/vocational qualification
- 2+ years of experience in regulatory affairs or related field
- Strong written and oral communication skills in English
- Knowledge of regional and national regulatory guidelines and EC regulations
- Proficiency with computer systems and ability to learn specialized software
- Excellent attention to detail and documentation quality
- Negotiation and interpersonal skills
What you'll be doing
- Prepare, review, and coordinate local regulatory submissions aligned with global strategy
- Provide regulatory strategy advice to internal clients at country level
- Serve as key contact for regulatory and ethical submission-related activities
- Coordinate with internal departments to ensure site start-up activities align with submission timelines
- Maintain trial status information in tracking databases accurately and timely
Privacy & handoff
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