Senior Country Approval Specialist

Thermo Fisher Scientific seeks a Senior Country Approval Specialist to manage regulatory submissions and coordinate approvals at the country level. This role involves preparing local submissions, providing regulatory strategy advice, and serving as the primary contact with regulatory authorities and internal stakeholders to ensure timely site activation and compliance.

Responsibilities

• Prepare, review and coordinate local regulatory submissions in alignment with global strategy
• Provide local regulatory strategy advice to internal clients and serve as primary contact with regulatory authorities
• Develop and implement country-specific submission strategy with technical expertise and project coordination
• Coordinate with internal departments to align site start-up and submission activities to critical timelines
• Maintain country study files, ensure compliance documentation, and proactively identify regulatory process issues

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 5+ years of experience in regulatory affairs or related field
• Excellent knowledge of regional/national country regulatory guidelines and EC regulations
• Strong written and oral communication skills with attention to detail
• Ability to mentor team members and work independently with minimal supervision
• Basic medical/therapeutic area and medical terminology knowledge
• Good negotiation and decision-making skills