Hong-May Therese Sim

Hong-May Therese Sim possesses extensive experience in regulatory affairs and quality assurance within the pharmaceutical and medical device sectors. At Biosensors International Group, Ltd, from May 2022 to March 2024, Hong-May served as Senior RA Executive II, leading projects related to the transition of legacy MDD products to MDR certification while focusing on change control and ISO 14971 standards. Prior to this role, at Vivo Surgical, Hong-May held dual roles that emphasized submissions for ISO 13485 certification, CE marking, and FDA approvals, showcasing strategic abilities in quality assurance and regulatory affairs. Experience at Bio-Rad Laboratories included pioneering efforts to secure essential licenses for controlled drugs and establishing compliant SOPs. Earlier academic involvement included mentoring students as an instructor at the National University of Singapore, following a postdoctoral fellowship at the National Institutes of Health where Hong-May developed novel bioassays. Hong-May holds a Bachelor's degree in Pharmacy and a PhD in Medicinal and Pharmaceutical Chemistry, both from the National University of Singapore.