Regional Associate, Quality and Regulatory Affairs-Asia Pacific
Fresenius Medical Care · Gurugram, HR ·
- Category
- Legal
- 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 authority’s notifications, quarterly reports, support adverse drug and device incidents reporting etc.
- Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements
- Update of regulatory databases as per department requirement. Expert in handling registration, submissions, and Artwork management system.
- Review regulatory strategies for national and Hub regulatory topics based on business requirements and broader regionally aligned regulatory affairs (RA) strategy
- Develop and implement SOPs on regulatory affairs related to different process