Senior Country Approval Specialist
Core
Manage preparation, review, and coordination of local regulatory submissions (MoH, EC) and develop country-specific submission strategies for clinical trials.
Role type
Senior IC country regulatory submission specialist
Builds
Regulatory compliance review packages, Patient Information Sheets, Informed Consent forms, and submission strategies
Domain
Clinical research / Regulatory affairs / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, local regulatory strategy development, stakeholder coordination with authorities, document development (PIS/ICF), contract scope identification, trial status data maintenance, SOP compliance, team mentoring
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, grant budget negotiation
Technologies
Database systems, regulatory software platforms
Responsibilities
Prepare and coordinate local regulatory submissions; Develop and implement local submission strategies; Serve as primary contact for investigators and regulatory authorities; Develop country-specific Patient Information Sheets and Informed Consent forms; Oversee country study files for SOP compliance; Mentor SSU team members; Identify and resolve regulatory process anomalies
Seniority
Senior, hands-on IC with mentorship responsibilities
