FSP Country Approval Specialist

Thermo Fisher Scientific seeks a Country Approval Specialist to manage and coordinate local regulatory submissions for clinical trials across multiple countries. The role involves preparing submissions, providing regulatory strategy guidance, and ensuring alignment with global submission timelines in a remote position.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions aligned with global strategy
• Provide local regulatory strategy guidance to internal stakeholders
• Serve as primary country-level contact for regulatory and ethical submission matters
• Coordinate site start-up activities with internal departments and investigators
• Maintain trial status information in tracking databases and ensure compliance documentation

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 2+ years relevant experience in regulatory affairs or clinical trial submissions
• Strong written and verbal communication skills
• Proficiency with regulatory databases and office software
• Working knowledge of regional and national regulatory guidelines
• Ability to work independently and collaboratively under direction
• Basic medical terminology and therapeutic area knowledge