Sandy Lee
About Sandy Lee
Sandy Lee is a Senior Director of Regulatory Affairs at Insmed Incorporated, with over 20 years of experience in the pharmaceutical industry. She specializes in US regulatory strategy and has a strong background in project management and regulatory submissions.
Work at Insmed
Sandy Lee currently holds the position of Senior Director of Regulatory Affairs at Insmed Incorporated, a role she has occupied since 2022. In this capacity, she oversees regulatory strategies and ensures compliance with industry standards. Prior to this role, she served as the Director of Regulatory Affairs at Insmed from 2020 to 2022. Her responsibilities include managing regulatory submissions and facilitating communication with regulatory bodies.
Education and Expertise
Sandy Lee earned her Bachelor of Science in Materials Science and Engineering from the Massachusetts Institute of Technology, completing her studies from 1995 to 1999. She furthered her education by obtaining a Master of Science in the same field from MIT, which she completed in 2000. Her educational background supports her expertise in regulatory affairs, particularly in US regulatory strategy, including IND, NDA, and ANDA submissions.
Background
Sandy Lee has over 20 years of experience in the pharmaceutical industry, focusing on regulatory affairs, project management, and pharmaceutical development. Her career includes significant roles at major companies such as Bristol-Myers Squibb and Taiho Oncology, where she contributed to regulatory strategies and compliance. She has held various positions, including CMC Documentation Scientist and Associate Director of Regulatory Affairs.
Achievements
Throughout her career, Sandy Lee has successfully implemented a harmonized global regulatory strategy and has expertise in preparing Meeting Requests and Briefing Packages for the FDA. Her proficiency in CMC technical writing has contributed to her effectiveness in regulatory submissions and project management within the pharmaceutical sector.