Senior Country Approval Specialist

Thermo Fisher Scientific seeks a Senior Country Approval Specialist to manage regulatory submissions and coordinate approval processes across countries. The role involves developing submission strategies, liaising with regulatory authorities, and ensuring timely site activation in alignment with global submission plans.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions aligned with global strategy
• Provide regulatory strategy advice to internal stakeholders and serve as primary authority contact
• Develop and implement local submission strategies with technical oversight and departmental coordination
• Oversee country study files and ensure compliance with company and client standard operating procedures
• Coordinate feasibility activities and site start-up timelines to meet critical path requirements

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 5+ years of experience in regulatory affairs or related field
• Excellent written and oral communication skills
• Strong knowledge of regional and national regulatory guidelines
• Proficiency with computer systems and ability to learn regulatory software
• Basic medical terminology and therapeutic area knowledge
• Ability to work independently and mentor team members