ZestAmigo
All jobs
Fresenius Medical Care logo
Fresenius Medical Care

1000 open roles

Regional Associate, Quality and Regulatory Affairs-Asia Pacific

Full-time
Posted 2 days ago
Apply on company siteYou’ll apply directly with the employer on Workday.
View original posting
Added to ZestAmigo
Last seen on employer site

Where you can work

On-site

Gurugram, Haryana, India

View location wording from the posting
Gurugram, HR, India

Employer description

  • 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
Track this application

Keep your own notes. Only you can mark an application as sent.

Report a problem with this listing

Sign in to report this listing.

More at Fresenius Medical Care

Apply on company site