FSP Country Approval Associate

Thermo Fisher Scientific seeks a Country Approval Associate to prepare, review, and coordinate regulatory submissions for clinical trials in Colombia. The role involves managing country-level approval processes, coordinating with internal teams, and maintaining regulatory compliance documentation in alignment with global strategy.

Responsibilities

• Prepare, review, and coordinate local ethical committee and Ministry of Health submissions aligned with global strategy
• Coordinate with internal departments to align submission activities with site activation and critical timelines
• Maintain trial status information in company tracking databases accurately and timely
• Support preparation of regulatory compliance packages and informed consent documents
• Assist with site grant budgets and payment schedule negotiations

Requirements

• Bachelor's degree or equivalent academic or vocational qualification
• 0-2 years of relevant experience in regulatory or submission-related activities
• Strong written and oral communication skills in English
• Proficiency with computer systems and ability to learn regulatory software
• Basic knowledge of regional and national regulatory guidelines
• Attention to detail and excellent documentation quality
• Ability to work independently or collaboratively under direction