Tannu Kumari

WORK HISTORY

EDUCATION

ABOUT TANNU KUMARI

Regulatory Submission Publisher1. Regulatory Submission Publishing:Publishing for US, Europe, CA, GCC and Row Countries.Preparation of EU submission delivery files in XML backbone for various request types (e.g, Var Type I, II, IAIN, Renewals, PSUSA, PIP)Compilation of documents and generation of output in eCTD using Insight Publisher/Lorenz Docubridge.Cross-review and validation of compiled outputs using Lorenz eValidator and EURS ValidatorDispatching submissions to Health Authorities (HA) via EMA and CESP gateways, FDA ESG Gatway.Publishing submissions in eCTD, paper, and Nees formats using Insight Publisher and DocuBridgeEnsuring the quality control of regulatory submissions for the team2. Document Publishing:Responsible for end-to-end document publishing and performing QA checks for Drug Safety Reports, Clinical and Non-Clinical Reports, SAP, NSR, Literature references, and Template ActivitiesFormatting and logic check of Annexes, Package Leaflets, SmPCs, and labeling in 25 languagesCoordinating with team members and authors to resolve compliance queries, ensuring timely delivery of individual and bulk activity reportsCompliance checking and creating citations for Literature ReferencesHandling minor publishing tasks such as protocol amendments, Investigator Brochures, and Safety Submissions paste.