Mai Yee Mishir
Head of Global Regulatory Affairs
Mai Yee joined Orphalan in June 2025 from Advanced Clinical where she was the Senior Director of Global Regulatory Affairs and has held positions of increasing responsibility at GE Healthcare (formerly Amersham Biosciences), Mallinckrodt Pharmaceuticals, Boehringer Ingelheim, Johnson & Johnson, with consultancy positions at IQVIA, PPD and ThermoFisher Scientific.
Mai Yee is responsible for developing and executing on global regulatory strategies with a focus on innovative treatments for rare diseases, overseeing compliance within Orphalan, whilst ensuring full adherence with regulations, regulatory requirements are integrated into all stages of product development, commercialization, policies, and procedures.
Mai Yee is a highly effective regulatory leader with over 30 years of industry experience, 23 years expertise in regulatory and 8 years spent in research, honed across all major healthcare sectors (Drugs, Devices, Consumer) at a global, regional and local level from the R&D bench to phase I-III clinical trials, Marketing & Post Approval, CMC, Labelling, Advertising & Promotions, Policy & Advocacy. Mai finds bringing a new product to market and working to define new regulatory pathways, when the path isn’t clear, particularly fulfilling. Expertise in understanding and navigating the current agency thinking and regulatory landscape is informed by years of service and breadth of experience. Mai provides the necessary edge for today’s products whether this is in development or marketed, ensuring compliance with legislation and is a foundational part of her skill set. Mai was nominated as part of a team and won the TOPRA award for Regulatory Excellence in the support category in Nov-2021, whilst working at PPD.
Mai has diverse therapeutic experience including rare diseases, auto-immune diseases, Cell & Gene Therapy, vaccines, oncology, ophthalmology, CNS, coupled with medical devices and OTC experience.
Mai holds a Ph.D. in Medicinal Chemistry and a B.Sc. First Class Honours degree in Chemical Science, from the University of Liverpool, UK.
