Kumar Santosh

Background

About Kumar Santosh

Familiar with compilation and submissions of NDA and ANDA and evaluate, prepare, organize and publish documentation comprising electronic and paper submissions, including eCTDs. Ensure that documents are prepared in accordance with FDA, ICH guidelines & internal guidelines/SOP and also familiar with other submissions types such as Safety Reports, Periodic AE Reports and Annual Reports • PDF Publishing of CSR, non-clinical reports, summary reports & others document types with ISI Toolbox • Publishing granular CSR, Periodic AE Reports, Summaries and others via ISI Publisher • Quality Assurance of study reports and submissions and Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling: assist Head of Regulatory Publishing in coordinating priorities for submissions. •Assist Regulatory Managers in the planning and tracking of submission project documentation. •Maintain submission tracking timeline tools with Project Management and Regulatory Affairs Liaison.