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 IC regulatory operations specialist (clinical trials)
Builds
Regulatory submission packages and country-specific study activation for clinical research programs
Domain
Clinical research services / Regulatory affairs
Required skills
Regulatory submission coordination, local regulatory strategy, stakeholder management with authorities, SOP compliance, project timeline alignment, contract scope identification, study file management, team mentoring
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, grant budget negotiation, feasibility coordination
Technologies
Clinical trial management systems, regulatory databases
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 critical paths; Develop country-specific patient information and consent forms; Oversee country study files; Mentor team members; Identify and resolve regulatory process anomalies
Seniority
Senior, hands-on IC with mentorship responsibilities
