Ruchi Sharma

Ruchi Sharma

Associate Director, Regulatory Affairs Cmc @ BeiGene

About Ruchi Sharma

Ruchi Sharma is the Associate Director of Regulatory Affairs CMC at BeiGene in San Mateo, California, with extensive experience in regulatory submissions and product life-cycle management. She has a background in molecular biology and biotechnology and has worked in various research and regulatory roles in the San Francisco Bay Area.

Current Position at BeiGene

Ruchi Sharma is currently working at BeiGene as the Associate Director, Regulatory Affairs CMC in San Mateo, California. In her role, she supports product life-cycle management and manages regulatory submissions for new drug development. Her position capitalizes on over a decade of experience in regulatory affairs.

Previous Roles at BeiGene and Achaogen

Before her current role, Ruchi served as a Senior Manager in Regulatory Affairs CMC at BeiGene for two years, from 2019 to 2021, in San Mateo, California. Prior to that, she was a Senior Manager in Regulatory Affairs CMC at Achaogen for 11 months in South San Francisco, CA, in 2018. These roles solidified her expertise in regulatory submissions and product life-cycle management.

Career at Gilead Sciences

Ruchi Sharma worked at Gilead Sciences in Foster City, CA, from 2010 to 2018. She first served as a Senior Research Associate in Discovery Biology for two years, and subsequently as a Regulatory Affairs Associate, CMC, for five years. Her tenure at Gilead Sciences provided her with extensive experience in both research and regulatory affairs.

Educational Background

Ruchi Sharma holds a Master of Biotechnology from San Jose State University, where she studied Molecular Biology from 2005 to 2007. She also obtained a B.S. in Molecular Biology from the same institution, studying from 2001 to 2005. Additionally, she holds the RAC (US) credential, a recognized certification in regulatory affairs.

Research and Early Career Roles

Ruchi started her career with research-oriented roles. She worked as a Graduate Research Intern at System Biosciences in Mountain View, CA, for two years starting in 2005. She also held positions at Genentech, Genelabs Technologies Inc. (now GlaxoSmithKline), Exelixis, and Gilead Sciences in various research capacities before transitioning into regulatory affairs.

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