Charge Registered Nurse - RN
freseniusmedicalcare
Regional Associate, Quality and Regulatory Affairs-Asia Pacific
freseniusmedicalcare· IN01 IND Fresenius Medical Care India Private Limited
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
Frequently Asked Questions
Is the salary disclosed for the Regional Associate, Quality and Regulatory Affairs-Asia Pacific position at freseniusmedicalcare?
The salary for this Regional Associate, Quality and Regulatory Affairs-Asia Pacific role at freseniusmedicalcare is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regional Associate, Quality and Regulatory Affairs-Asia Pacific position at freseniusmedicalcare located?
This Regional Associate, Quality and Regulatory Affairs-Asia Pacific role at freseniusmedicalcare is based in Gurugram, HR. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regional Associate, Quality and Regulatory Affairs-Asia Pacific role at freseniusmedicalcare full-time or part-time?
This is listed as a Full time position. It is posted as a Regional Associate, Quality and Regulatory Affairs-Asia Pacific role in the IN01 IND Fresenius Medical Care India Private Limited department at freseniusmedicalcare.
Which team or department does the Regional Associate, Quality and Regulatory Affairs-Asia Pacific at freseniusmedicalcare belong to?
This Regional Associate, Quality and Regulatory Affairs-Asia Pacific position is part of the IN01 IND Fresenius Medical Care India Private Limited department at freseniusmedicalcare. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regional Associate, Quality and Regulatory Affairs-Asia Pacific position at freseniusmedicalcare?
Click the "Apply Now" button on this page. You will be redirected to freseniusmedicalcare's official application portal hosted on workday where you can submit your application directly.
When was the Regional Associate, Quality and Regulatory Affairs-Asia Pacific job at freseniusmedicalcare posted?
This Regional Associate, Quality and Regulatory Affairs-Asia Pacific position at freseniusmedicalcare was posted on Sep 24, 2026. Apply as soon as possible — early applications are often reviewed first.
Regional Associate, Quality and Regulatory Affairs-Asia Pacific
freseniusmedicalcare
You'll be redirected to freseniusmedicalcare's official application page on Workday.