Michelle Cheung

Senior Manager, Regulatory Operations at Ardelyx

Michelle Cheung has extensive work experience in the field of regulatory operations. Michelle began their career at Genentech as a Regulatory Information Specialist, where they prepared paper and electronic submissions of non-clinical study reports and annual reports. Michelle then worked at GlaxoSmithKline as an Electronic Submission Associate, responsible for preparing and formatting IND, BLA, and NDS submissions. Michelle then joined Facet Biotech where they served as a Regulatory Technical Publisher, responsible for assembling and preparing eCTD submissions. Michelle later worked at Anesiva as a Senior Regulatory Publisher, coordinating the workflow and activities of Regulatory Publishing. Michelle then joined Elan Pharmaceuticals as a Sr. Regulatory Submissions Associate, performing activities associated with the preparation of eCTD submissions. Michelle then worked at Onyx Pharmaceuticals as a Manager in Regulatory Operations/Regulatory Submission Specialist, where they recruited, hired, trained, and supervised a team and prepare and maintain regulatory submission documents. Michelle then joined Pharmacyclics, an AbbVie Company, as a Senior Manager in Regulatory Operations and successfully managed the company's second NDA and five sNDA submissions. Michelle'smost recent position was at Ardelyx, Inc., where they served as a Senior Manager in Regulatory Operations, managing the filing of two NDAs and new IND Applications. Throughout their career, Michelle has demonstrated strong leadership and technical skills in regulatory operations.

Michelle Cheung attended Oregon State University from 1995 to 2000, where they earned two Bachelor of Arts (BA) degrees. Michelle'sfirst degree was in Graphic Design, and their second degree was in Multimedia & Web Design.

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