About this role
Job title: Regional Associate, Quality and Regulatory Affairs-Asia Pacific
Job Overview Fresenius Medical Care serves around 292,000 dialysis patients worldwide and provides products in more than 140 countries. We are a vertically integrated medical technology (MedTech) and healthcare service company made up of three operating segments: Care Delivery, Value-Based Care, and Care Enablement. This structure allows us to provide the full spectrum of healthcare services, systems, devices, technologies, products, and pharmaceuticals to deliver high-quality care to people living with kidney disease.
Job Description This role involves lifecycle management of pharmaceutical products and medical devices in Asia Pacific markets, including administrative and CMC variations, labeling, safety updates, and annual reports. The candidate will work with the Country LRA, Cluster Hub, Global CDRA, and labeling team for strategy preparation and implementation for Asia Pacific countries on various regulatory projects, including label review and maintenance to ensure correctness of label content. Project management responsibilities include strategy preparation and review for regulatory projects across all countries in Asia Pacific, acting as a subject matter expert and assisting country regulatory teams with day-to-day troubleshooting and presenting solutions to project-related problems. The role includes setting up and maintaining regulatory records with updated product registration status and registered product information, coordinating with Asia Pacific countries on post-market approval requirements to meet internal and external timelines (e.g., PSUR, health authority notifications, quarterly reports, and support for adverse drug and device incident reporting). The candidate will monitor, evaluate, and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and contribute to the development of new regulatory requirements. Responsible for updating regulatory databases as per department requirements, expert in handling registration, submissions, and artwork management systems. Review regulatory strategies for national and hub regulatory topics based on business requirements and broader regionally aligned regulatory affairs strategy. Develop and implement SOPs on regulatory affairs related to different processes.
Care in every moment.
Connection in every step.