FSP Country Approval Specialist II

Thermo Fisher Scientific seeks a Country Approval Specialist II to manage regulatory submissions and coordinate clinical trial approvals across countries. The role involves preparing and reviewing local submissions, providing regulatory strategy guidance, and ensuring alignment with global submission timelines in a remote position based in Denmark, Norway, or Sweden.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions aligned with global strategy
• Advise internal stakeholders on local regulatory and ethics committee strategy
• Serve as primary country-level contact for regulatory and ethics submission activities
• Coordinate site start-up activities with submission timelines to meet activation critical path
• Maintain trial status records and study files according to company and client procedures

Requirements

• Bachelor's degree or equivalent formal academic qualification
• 2+ years of experience in relevant regulatory or clinical operations
• Strong written and oral communication abilities
• Proficiency with regulatory guidelines and medical terminology
• Attention to detail and quality in documentation
• Knowledge of regional and national regulatory requirements
• Competency with computer systems and software learning