Poornima Sureshkumar

Submission preparation for International Marketing Authorisations ICH-GCP/National and International Fundamentals of Pharmaceutical Regulations and Medical Devices EU MDR, IVDR Documentation: Clinical Study- Pharmaceuticals and Medical devices Regulatory affairs: Compliance to AMG, MDR and IVDR

Managed submissions to European Framework Program (FP7), Documented technical reports for three FP7 projects in stem cell research (DETECTIVE, ESNATS, STEMCAM), Coordinated communications between project partners from Academic research with Industry Prepared regular project reports Performed Quality control on project documentations and coordinated with project management team in assessment of project delays, GLP, SOPs, QMS

Served as the Subject Matter Expert (Product Reference) for Nielsen Services- A Market Research project (Client located in the USA) Performed Classification, coding, and validation using Citrix based server Handled client communications Performed quality management tasks as the team’s internal quality monitor. Tasks included error identification, clarification/correction, and providing internal training Performed Data management tasks