Prepare, review, and maintain regulatory submissions and documentation in compliance with applicable regulatory guidelines. Coordinate preparation of dossiers, variations, renewals, amendments, and other regulatory submissions. Review product documentation, specifications, analytical data, stability
Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning. Key Individual Ac
Partner with Regulatory Affairs stakeholders to identify opportunities for AI-enabled process improvements across regulatory planning, submission preparation, document management, lifecycle management, and regulatory intelligence. Design, develop, and deploy production-ready AI applications, AI agen
SQR: Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient saf
PURPOSE AND SCOPE: The E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert & Transformation Lead is accountable for driving global standardization, operational excellence, and transformation across the end-to-end (E2E) RA & QM value chain. RA & QM functionality sits overall within t
Build, lead and develop a high-performing Regulatory Affairs team-recruitment, onboarding, coaching, performance management and succession planning, in partnership with global SQR leadership and GBS enabling functions Hold end-to-end accountability for regulatory deliverables as an integral part of
General: Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards. Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements. Exercises sound judg
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