Regional Associate, Quality and Regulatory Affairs-Asia Pacific
Fresenius Medical Care · Gurugram · onsite · Posted 24d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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
Sourced from foundit
Skills
Registration submissionsAdministrative and CMC variationsLabel review and maintenanceSafety updatesAnnual ReportsLabellingProject ManagementArtwork Management System
About Fresenius Medical Care
Fresenius Medical Care
Healthcare
201
employees
1996
30 years old
Massachusetts
United States
₹8.2L PA avg
Avg at Fresenius Medical Care
About
Innovative products, therapies and services creating a future worth living for our patients. Chronic and acute kidney dialysis and therapeutic apheresis.
Industries
Healthcare
Employee ratings
10 reviews
3.6/ 5
Culture
3.2
Career growth
2.5
Work-life
3.4
Employees rate it well for
Job Security37Overall Company36
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