FSP Country Approval Specialist

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

Responsibilities

• Prepare, review, and coordinate local regulatory submissions aligned with global strategy
• Provide regulatory strategy advice to internal clients under guidance
• Coordinate site start-up activities with internal departments to ensure timeline alignment
• Maintain trial status information in PPD tracking databases accurately and timely
• Coordinate feasibility activities and develop country-specific regulatory documents as needed

Requirements

• Bachelor's degree or equivalent formal qualification
• 2+ years of relevant experience in regulatory or clinical trial management
• Strong written and oral communication skills in English
• Knowledge of regional and national regulatory guidelines and EC regulations
• Excellent attention to detail and documentation quality
• Good negotiation and interpersonal skills
• Proficiency with computer software and ability to learn new systems