Gary Low

Regulatory Affairs CMC at Ultragenyx Pharmaceutical Inc.
Summary
Gary Low is a professional with over 12 years of cGMP clinical and commercial biotech experience in start-up, recombinant protein manufacturing, analytical QC, and QA operations under 21 CFR 210 and 211 regulations.
He also has regulatory affairs experience in the CMC group, working on submissions for IND, NDA, and regulatory agency responses.
With proven abilities in debugging, validating, commissioning, licensure, release product testing, and quality assurance oversight, Gary excels in change management, processes, and equipment.
He holds a Master of Science in Regulatory Science from the University of Southern California, a Bachelor of Science in Biochemistry & Molecular Biology, and a Bachelor of Arts in Economics from the University of California, Davis.
Gary Low has held various roles in reputable organizations such as Ultragenyx Pharmaceutical Inc., Gilead Sciences, Teva Pharmaceuticals, Amgen, Baxter Healthcare, and Genentech, showcasing his diverse skill set and experience in the biotech and pharmaceutical industry.
Passionate about ensuring quality assurance and compliance, Gary combines his technical expertise with strong communication skills to build collaborative and effective teams.
Currently seeking a challenging opportunity in a biotech/pharmaceutical firm, Gary Low is poised to leverage his background to contribute effectively in a dynamic work environment.