As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites
Job Summary
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Matching Summary
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.