FSP Country Approval Specialist

Thermo Fisher Scientific seeks a Country Approval Specialist to prepare, review, and coordinate local regulatory submissions for clinical trials across multiple countries. The role involves managing country-level regulatory strategy, liaising with internal teams and investigators, and maintaining compliance documentation in alignment with global submission timelines.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions (Ministry of Health, Ethics Committees, national applications) aligned with global strategy
• Provide country-level regulatory strategy guidance to internal clients
• Serve as key contact for regulatory and ethical submission activities at country level
• Coordinate with internal departments to align site start-up activities with submission timelines and critical path
• Maintain trial status information and country study files in PPD tracking databases per standard procedures

Requirements

• Bachelor's degree or equivalent formal academic or vocational qualification
• 2+ years of experience in regulatory submissions or related field
• Strong written and oral communication skills
• Knowledge of regional and national regulatory guidelines and EC regulations
• Proficiency with computer systems and ability to learn regulatory software
• Attention to detail and quality documentation practices
• Basic medical terminology and therapeutic area knowledge