Director, Quality External Affairs – JAPAC
Dinesh is the Director, External Affairs Quality supporting Amgen’s outward facing efforts in Japan Asia Pacific. Responsible for supporting and shaping the external environment (policy / advocacy work) on quality regulatory requirements and expectations including representing Amgen in various external organizations.
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, Dinesh held several roles with increasing responsibilities. His main role was to manage, oversee and drive product review, licensure and administer the pre-market regulatory policy and framework for medicines covering drugs and biologics including biotherapeutics, vaccines, combination products and biosimilars.
He has also played several key roles in multiagency international consortiums and WHO initiatives working towards regulatory capability building, shaping regulatory landscape, regulatory convergence, and mutual reliance. Prior to his regulator roles for 10 years, Dinesh held many positions in academia, biopharmaceutical manufacturing and human disease diagnostic industries in India, USA and Singapore for over 20 years
Dinesh holds PhD in Cell & Molecular Biology and he is a Certified Quality Auditor and Biomedical Auditor.