Anand Gandhi

Team Lead @Genpact

Mumbai, IN

Expert in Regulatory submissions (Submission level & Document level) for EU and US & GCC, Swiss countries, ROW etc.• Experience in eCTD document preparation, building structure, compilation, publishing using tools Liquent Insight Publisher (V6.2), Liquent Insight Validator, EURS Validator, Lorenz Validator, Acuta PDF toolbox, ISI toolbox, Citation Wizard, etc.• Expert in publishing submissions i.e. MAA, NDA, BLA, IND, MRP, DCP, CP NP etc.• Publishing submissions i.e Nees, Paper, eCTD for USFDA, EU, HC, GCC, Swiss etc.• Expert in publishing submissions: Amendments, Safety reports (PSUR), CMC/Safety/Efficacy supplements, Annual Reports, Variations, Baseline, Clinical Study Reports etc.• Compliance, creation of internal and external links in eCTD, NEES format.• Performing QC checks to ensure the high quality of submission.• Checking, Linking, Bookmarks, QC/review of documents.• Dispatching published outputs via Health Authority Gateway - EMA, ESG.• Support Global Regulatory affairs in maintaining Regulatory information management system(RIMS)- Liquent InSight- Creating/Updating Application in RIMS: MAA/NDA- Creating/Updating Events in RIMS: Variation/Renewal/Data admin- Creating/Updating Registrations, Product detail sets, sequence, tasks.

Savitribai Phule Pune University

Master's degree, Pharmacy