Senior Country Approval Specialist
Core
Manage the preparation, review, and coordination of local regulatory submissions (MoH, EC, gene therapy approvals, viral safety dossiers) in alignment with global strategy.
Role type
Senior regulatory submission specialist (clinical trial start-up)
Builds
Regulatory compliance review packages, local submission strategies, and country-specific patient information documents
Domain
Life sciences / Clinical trials / Regulatory affairs
Required skills
Regulatory guideline knowledge, submission coordination, local strategy development, stakeholder liaison, documentation quality, team mentorship
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, database management
Technologies
Regulatory databases, submission management software
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; Oversee country study files; Mentor team members; Identify and resolve regulatory process anomalies
Seniority
Senior, hands-on IC with mentorship responsibilities