Country Approval Specialist

Job Summary

Managing the preparation and coordination of local regulatory submissions, the full-time Sr. Country Approval Specialist will ensure compliance with global submission strategies while serving as the primary contact for investigators and local regulatory authorities, all in a fully remote capacity.

Key responsibilities

• Prepare, review, and coordinate local regulatory submissions in alignment with global strategies
• Provide local regulatory strategy advice and develop implementation plans in collaboration with internal departments
• Act as the key contact for submission-related activities and ensure timely management of submissions

Required qualifications

• Bachelor's degree or equivalent relevant qualification
• 2-5+ years of experience in regulatory submissions or related fields
• Knowledge of regional/national regulatory guidelines and EC regulations
• Experience in coordinating with cross-functional teams and managing timelines
• Ability to mentor and provide guidance to team members