The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies
Job Summary
The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies.
This role serves as the primary contact for investigators and local regulatory authorities to ensure timely submission management and site activations.
Join a global team at Thermo Fisher Scientific that values passion, innovation, and scientific excellence while offering opportunities for professional development.
Matching Summary
The Principal Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
8+ years regulatory submission experience
Knowledge of MoH and EC regulations
Experience with gene therapy approvals
Ability to mentor SIA team members
Strong negotiation skills for contracts
Nice-to-have
Excellent interpersonal communication skills
Ability to work independently with minimal supervision
Team building and collaborative mindset
Basic medical terminology knowledge
Key Requirements
Bachelor's degree or equivalent
8+ years of relevant experience
Knowledge of regional/national regulatory guidelines