Michelle Lee

Michelle Lee has extensive experience in regulatory operations within the pharmaceutical and biotechnology sectors. Currently serving as the Director of Regulatory Operations at TerSera Therapeutics, Michelle has previously held the position of Sr. Manager of Regulatory Operations - EDMS at Novartis Gene Therapies. Additional roles include Sr. Regulatory Solutions Analyst and Regulatory Solutions Analyst at PRA Health Sciences, as well as various positions at Takeda Pharmaceuticals, including Regulatory Solutions Analyst, Business System Support Specialist, Sr. Submission Technician, and Document Coordinator. This diverse background reflects a strong expertise in regulatory processes and compliance.