Country Approval Associate

Coordinate, review, and manage country submissions aligned with the global submission strategy; support local MoH submissions; liaise with internal departments to ensure site start-up activities align with submission timelines and critical paths for site activation; work with start-up CRAs to prepare regulatory review packages; assist in developing country-specific patient information sheets and informed consent form documents; assist with grant budgets and payment schedules negotiations; maintain trial status information in tracking databases; ensure local study files and filing processes meet SOPs; stay updated on regulatory guidelines and SOPs; collaborate in a team environment to deliver timely regulatory and ethical submissions across the country.