Vijaya Nag Thota
Sr General Manager-regulatory Biologics, Peptides & Vaccines @CuraTeQ Biologics
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WORK HISTORY
Sr General Manager-regulatory Biologics, Peptides & Vaccines @CuraTeQ Biologics
Hyderabad, IN
EDUCATION
Barkatullah Vishwavidyalaya
M.Sc, Microbiology and Immunology
ABOUT VIJAYA NAG THOTA
Proactive result oriented professional with progressive expertise in developing and manufacturing recombinant biosimilars from various expression systems.# Expertise in implementation of QbD for development & manufacturing of biosimilars with top notch QSE profiles with expedited regulatory path from clone to commercialization.# Accomplished product filing (DMF, CMC, CTD) & obtained product marketing authorizations with various DRA\'s across the globe. Experienced in filing CEP & US-Type II DMF.# Successfully lead technology assimilation & transfers for various biosimilars with domestic & international clients & thorough understanding in global drug regulatory procedures.# Expertise in project management with emphasis in cGMP laboratory start-up research, facility, utility and process designing, qualification & validations.
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