Stephanie Lee
About Stephanie Lee
Stephanie Lee is a Senior Manager of Regulatory Affairs at Mirum Pharmaceuticals, where she has worked since 2019. She has extensive experience in regulatory affairs, having held various positions at companies such as Tobira Therapeutics, Gilead Sciences, Titan Pharmaceuticals, Cell Genesys, and Allergan.
Current Role at Mirum Pharmaceuticals
Stephanie Lee serves as the Senior Manager of Regulatory Affairs at Mirum Pharmaceuticals. She has held this position since 2019, contributing to the regulatory strategies and compliance efforts of the company. Based in Foster City, California, she oversees regulatory submissions and ensures adherence to industry standards.
Previous Experience in Regulatory Affairs
Prior to her current role, Stephanie Lee accumulated extensive experience in regulatory affairs across several organizations. She worked at Allergan as a Manager in Regulatory Affairs from 2016 to 2018. Before that, she served as a Senior Regulatory Affairs Specialist at Tobira Therapeutics from 2014 to 2016 and as a Regulatory Affairs and QA Documentation Specialist from 2013 to 2014 at the same company.
Early Career in Quality Assurance and Regulatory Affairs
Stephanie Lee began her career in regulatory affairs and quality assurance at Cell Genesys, where she worked as a QA Documentation Specialist from 2003 to 2006. She then transitioned to Titan Pharmaceuticals as a Regulatory Affairs and QA Documentation Specialist from 2007 to 2008, followed by a role at Gilead Sciences as a Quality Documents and Training Specialist from 2009 to 2011.
Educational Background
Stephanie Lee holds a Bachelor's degree from California State University - East Bay. Additionally, she has completed a Project Management Certificate program at UC Berkeley Extension, enhancing her project management skills relevant to her regulatory affairs role.