Sr. Ctry Approval Spec (CAS-EC)
Core
Manage the preparation, review, and coordination of local regulatory submissions (MoH, EC, gene therapy, viral safety) 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
Deliverable
client delivery
Required skills
Regulatory submission preparation, local regulatory strategy, coordination with authorities, database maintenance, SOP compliance, contract scope identification, feasibility coordination, patient information sheet development
Preferred skills
Mentorship, negotiation, site activation alignment
Technologies
Clinical trial databases, regulatory submission software
Responsibilities
Prepare and coordinate local regulatory submissions; Provide local regulatory strategy advice; Serve as primary contact for investigators and authorities; Maintain trial status information in databases; Oversee country study files; Develop country-specific patient information sheets; Coordinate site start-up activities with submission timelines.
Seniority
Senior, hands-on IC with mentorship responsibilities
