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Sri Divya Harkara MS-RA, RAC, PMP is an experienced regulatory operations professional currently serving as a Manager in Regulatory Publishing at Regeneron. They possess a Master’s degree in Regulatory Affairs for Drugs Biologics and Medical Devices from Northeastern University and have over 12 years of expertise in regulatory submissions, including preparing and submitting IND applications, NDAs, and BLAs. Previously, they held positions at companies such as Sanofi and Genzyme, where they developed submission strategies, managed project timelines, and ensured compliance with regulatory guidelines. Sri Divya is well-versed in eCTD publishing tools and has demonstrated strong leadership and collaboration skills throughout their career.