Position Overview
Description
Role description
Product registration & maintenance
Develop the regulatory strategy/plan for the earliest launch of new products on best conditions (indication, forms, minimum documents requirements etc) in Korea by sourcing necessary documents from HQ’s worldwide regulatory function.Implement/manage products registration procedures required by Korean pharmaceutical regulation to achieve the earliest market entry.Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue.Update the safety information in line with the CDS and other reference countries.Product lifecycle maintenance: Keep product license to be compliant with regulations.Product QA
Package compliance: Secure the package compliance in line with the local regulation and AZ compliance.Responsible for company’s compliance into all rel...