Senior Country Approval Specialist
Core
Manage preparation, review, and coordination of local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers, import licenses) for clinical trials in alignment with global strategy.
Role type
Senior regulatory submission specialist (clinical trials)
Builds
Regulatory compliance review packages and country-specific submission documentation
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Regulatory guideline knowledge, submission strategy development, stakeholder coordination, technical expertise, compliance review, database management, SOP adherence, mentorship, issue resolution, contract review
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, grant budget support, feasibility coordination
Technologies
Clinical trial databases, regulatory submission software, office equipment
Responsibilities
Prepare and coordinate local regulatory submissions; Provide local regulatory strategy advice; Serve as primary contact for investigators and authorities; Develop country-specific patient information sheets and consent forms; Oversee country study files; Mentor team members; Identify and resolve regulatory process anomalies.
Seniority
Senior, hands-on IC with mentorship responsibilities
