Cristalenia Andrikos
About Cristalenia Andrikos
Cristalenia Andrikos is a Senior Associate in Submissions Operations Management at BeiGene with over a decade of experience in regulatory operations within the pharmaceutical, medical device, and biotechnology industries.
Current Position at BeiGene
Cristalenia Andrikos currently holds the position of Senior Associate Submissions Operations Management at BeiGene, located in San Mateo. In her role, she focuses on streamlining documentation and FDA submission processes to ensure compliance with regulatory standards. Her background in various aspects of regulatory operations positions her as a key asset within the company's submissions operations.
Previous Role at Five Prime Therapeutics, Inc.
From 2018 to 2019, Cristalenia Andrikos worked as a Regulatory Operations Manager at Five Prime Therapeutics, Inc. in South San Francisco, CA. During her tenure, she was responsible for overseeing regulatory documentation and submission processes, ensuring compliance with FDA guidelines. This role allowed her to further hone her expertise in regulatory operations within the biotechnology industry.
Experience at Medtronic Diabetes
Cristalenia Andrikos served as a Senior Regulatory Operations Specialist at Medtronic Diabetes from 2014 to 2018 in Northridge, CA. In this capacity, she was instrumental in maintaining compliance with FDA regulations and optimizing submission workflows. Prior to this, she also worked as a Regulatory Operations Specialist at Medtronic from 2012 to 2014, further developing her skills in regulatory operations within the medical device industry.
Educational Background
Cristalenia Andrikos earned her Master of Business Administration (M.B.A.) in Finance, General from California Lutheran University, from 2009 to 2011. She also holds a Bachelor of Arts (B.A.) in Economics from Concordia University, completed between 2004 and 2006. Her educational background in finance and economics has provided her with a comprehensive understanding of business operations, which she applies to her regulatory roles.
Industry Expertise
With over a decade of experience in regulatory operations across the pharmaceutical, medical device, and biotechnology industries, Cristalenia Andrikos specializes in streamlining documentation and FDA submission processes. She has a proven track record of ensuring compliance with FDA guidelines within established timelines. Her experience includes training staff to achieve operational excellence and driving continuous improvements in regulatory operations.