Country Approval Associate

Thermo Fisher Scientific seeks a Country Approval Associate to support regulatory submissions for clinical trials. The role involves preparing documentation, coordinating with internal teams and sites, and maintaining compliance with global submission strategies and regional regulations.

Responsibilities

• Prepare, review, and coordinate ethics committee and ministry of health submissions aligned with global strategy
• Coordinate with internal departments to synchronize site start-up activities with submission timelines
• Assist in preparing regulatory compliance packages and informed consent form documents
• Maintain trial status information and study files in tracking databases per standard operating procedures
• Support grant budget negotiations and payment schedule agreements with study sites

Requirements

• Bachelor's degree or equivalent formal qualification
• 0-2 years relevant experience in regulatory or clinical trial submissions
• Strong written and verbal communication skills
• Knowledge of regional and national regulatory guidelines
• Proficiency with computer systems and ability to learn specialized software
• Attention to detail and documentation quality
• Basic medical terminology and therapeutic area knowledge