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Samyukta B. is a seasoned regulatory affairs professional with over 11 years of experience in the pharmaceutical industry, including 7 years in regulatory CMC. Currently serving as a Senior Manager - Regulatory CMC at Avidity Biosciences, Inc., Samyukta previously held similar roles at Sarepta Therapeutics and GSK, where they led various regulatory initiatives and developed strategies for product submissions. Samyukta's background includes hands-on experience in lab-scale cell culture and purification of biological products, supported by a Master of Science in Biotechnology with a concentration in Regulatory Affairs from The Johns Hopkins University. They hold an RAC-DRUGS certification and possess extensive knowledge of cGMP, ICH, and global regulations.