Principal Country Approval Specialist
Core
Manage the preparation, review, and coordination of local regulatory submissions for clinical trials in alignment with global strategy.
Role type
Senior IC regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and country-specific study files for clinical trials
Domain
Clinical research services / Life sciences
Required skills
Regulatory submission strategy, local regulatory authority liaison, project coordination, contract review, SOP compliance, mentorship, regulatory intelligence systems
Preferred skills
Medical/therapeutic area knowledge, grant budget negotiation, feasibility coordination
Technologies
Regulatory intelligence systems, database management
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, special national applications); Provide local regulatory strategy advice to internal clients; Serve as primary contact for investigators and local regulatory authorities; Oversee country study files and ensure compliance with SOPs; Direct and mentor other SIA individuals; Maintain country master document templates and regulatory intelligence systems.
Seniority
Senior, hands-on IC with mentorship responsibilities