+ Dealing with lifecycle management of pharmaceutical product and medical devices in Asia Pacific Markets including administrative and CMC variations, Labelling, Safety updates, and Annual reports.
+ Work with Country LRA, Cluster Hub, Global CDRA, labelling team for strategy preparation and implementation for Asia Pacific countries for different regulatory projects. Label review and maintenance, ensure correctness of labels content
+ Project Management- Responsible for strategy preparation, review for regulatory projects across all countries in Asia Pacific. Act as a subject matter expert and help the countries regulatory team with day-to-day trouble shooting activities, presenting solutions to project related problems.
+ Setup and maintain regulatory records with updated product registration status and registered product information.
+ Coordinate with Asia Pacific countries on post market approval requirements to meet internal & external timelines e.g., PSUR, health autho...