The Senior Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies
Job Summary
The Senior 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 a commitment to scientific excellence.
Matching Summary
The Senior Country Approval Specialist manages the preparation, review, and coordination of local regulatory submissions in alignment with global strategies.
Skills & Requirements
Must-have
5+ years regulatory experience
Country submission preparation
MoH and EC regulatory knowledge
Local regulatory strategy development
Site start-up activity coordination
Nice-to-have
Strong negotiation skills
Mentoring team members
Excellent communication abilities
Patient information sheet development
Grant budget negotiation assistance
Key Requirements
Bachelor's degree or equivalent
5+ years relevant experience
Knowledge of regional/national regulatory guidelines