Manasi Shinde
Lead @Tata Consultancy Services
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WORK HISTORY
Lead @Tata Consultancy Services
Mumbai, IN
Drug regulatory affairs
EDUCATION
Late Shri. Vishnu Waman Thakur Charitable Trust VIVA Institute of Technology at Shirgoan Post Virar Tal Vasai Dist Thane
Master of Science
University of Mumbai
Master of Science - MS
ABOUT MANASI SHINDE
Publishing for Major regulatory markets like US, EU, CA, GCC, AU etc and also for non-regulated markets. I have worked on Adobe PDF library to perform PDF properties related activities like correction, verification in the most standard way. I can manage hyperlink, bookmark activity in easier & faster way; Quick/ Auto/ Copy/ Auto-correct features helps to avoid redundant activities of Hyperlink in each & every submission. Also, I have worked on e-CTD naming conventions as per market requirements & audit trails for every activity in compliance with 21 CFR guidelines etc.Tender bid specialistI work on various regions like Europe, Latam, APAC & PAHO. I work to procure and author HQ-CMC & HQ-RAI documents and fulfil the requirements of Hospital & Pharmaceutical Tender business by submitting these documents to Health Authorities like EUDRA, USFDA, Health CANDA, CDSCO etc. also authoring of documents likestability data, Patent information, Letter of Authorization etc. is part of my profile. I also worked on quality documents like control of drug product, drug substances, excipients & various declarations. Worked on 21 CFR for NDA approval letters for all regulatory, non-regulatory markets. Also regulatory submission achieving and document management process of tender bids which include around 2 years of experience in Veeva Vault, specifically in end-end Regulatory information management (RIM) to enhance quality of regulatory documents and streamline compliance processes in Global markets.
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