Myleen Ignacio
About Myleen Ignacio
Myleen Ignacio serves as the Vice President and Head of Global Regulatory Affairs at Mirum Pharmaceuticals, bringing over two decades of experience in regulatory affairs across various pharmaceutical companies. She has a strong background in rare diseases and has contributed to numerous drug applications and regulatory submissions throughout her career.
Work at Mirum Pharmaceuticals
Myleen Ignacio currently serves as the Vice President and Head of Global Regulatory Affairs at Mirum Pharmaceuticals, a position she has held since 2021. Prior to this role, she was the Executive Director and Head of Regulatory Affairs at the same company from 2019 to 2021. In her current role, she oversees regulatory strategies and ensures compliance with global regulatory requirements, contributing to the advancement of Mirum's product pipeline.
Previous Experience in Regulatory Affairs
Myleen Ignacio has extensive experience in regulatory affairs across various pharmaceutical companies. She worked at Valeant Pharmaceuticals North America as a Senior Manager in Regulatory Affairs from 2010 to 2011. Her career includes roles at Ultragenyx Pharmaceutical Inc., where she served as Associate Director and later as Director of Regulatory Affairs from 2014 to 2019. Additionally, she held positions at Neurocrine Biosciences, Arena Pharmaceuticals, BioMarin Pharmaceutical Inc., and Amylin Pharmaceuticals, accumulating over 20 years of experience in the field.
Education and Expertise
Myleen Ignacio holds multiple degrees from the University of Southern California, including a Master of Science in Regulatory Science and a Master's degree in Medicinal and Pharmaceutical Chemistry. She also earned a Bachelor of Science in Biochemistry and Cell Biology and a Bachelor of Arts in English from UC San Diego. Ignacio possesses Regulatory Affairs Certification (RAC) and has specialized expertise in areas such as Metabolism and Endocrinology, Gastroenterology, Neurology, Dermatology, and Cardiovascular health.
Regulatory Experience and Contributions
Ignacio has direct regulatory experience in leading and contributing to the filing of numerous applications, including three New Drug Applications (NDAs), one Biologics License Application (BLA), four Marketing Authorization Applications (MAAs), and 16 Investigational New Drug (IND) applications. Her extensive experience includes interactions with regulatory authorities in the US, Canada, and the EU, showcasing her capability in navigating complex regulatory landscapes.
Background in Research and Development
Before transitioning into regulatory affairs, Myleen Ignacio worked in research roles, including as a Research Scientist at The Scripps Research Institute and as a Research Technician at the Salk Institute for Biological Studies. She also worked as an Analytical Chemist at TriLink BioTechnologies. This background in research has provided her with a strong foundation for her regulatory career, enhancing her understanding of the scientific principles underlying drug development.