Dinesh is the Director of External Affairs Quality at Amgen Biotechnology Singapore supporting Amgen's outward-facing efforts in Japan Asia Pacific and Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate, and deliver impact in the evolving external GxP landscape. Additionally, Dinesh currently holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor's University, Malaysia.
Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Medicine Regulatory Agency, Health Sciences Authority (HSA). During his 10 years tenure in HSA, his main role was to manage, oversee and drive the key development, review, licensure, and administer the pre-market regulatory framework for western medicines covering innovative drugs, generics, biologics including, biotherapeutics, vaccines, combination products, and biosimilars. He has also played several key roles in multiagency consortiums and WHO initiatives working towards capability building, shaping regulatory landscape, regulatory harmonization, and mutual reliance. Prior to the roles in the regulatory agency, Dinesh held many positions in Biopharmaceutical and Medical Device industries as well as in Academia for over 20 years.
Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is an American Society for Quality Certified Quality Auditor and Biomedical Auditor. He has also earned certifications in Clinical Trials Management and Healthcare Policy and Governance.
EVENTS & ACTIVITIES (Speaking, Spoken, and Authored)