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 scientific excellence while delivering breakthroughs.
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 submission experience
Knowledge of MoH and EC regulations
Experience with gene therapy approvals
Informed Consent form document development
Site start-up activity coordination
Nice-to-have
Strong negotiation skills for grant budgets
Mentoring capabilities for team members
Excellent interpersonal communication skills
Ability to work independently with minimal supervision