Senior 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 regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and country-specific study activation plans
Domain
Clinical research services / Regulatory affairs
Required skills
Regulatory submission strategy, local regulatory authority liaison, clinical trial site activation coordination, contract scope identification, SOP compliance, database maintenance, team mentoring
Preferred skills
Medical/therapeutic area knowledge, grant budget negotiation, feasibility activity coordination
Technologies
Clinical trial databases, regulatory submission software
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, special applications), provide local regulatory strategy advice, serve as primary contact for investigators and authorities, ensure alignment of submission processes with site activation timelines, maintain country study files, mentor team members, identify and resolve regulatory process anomalies
Seniority
Senior, hands-on IC with mentorship responsibilities