Dinesh is currently responsible for supporting Amgen’s outward facing efforts to collaborate effectively with industry PEERS and regulators to engage, understand, translate and deliver impact in the evolving external GxP landscape.
Prior to Amgen, Dinesh held the role of Director, Therapeutic Products Branch at Health Sciences Authority (HSA), Singapore. During his 10 years tenure in the agency, his main role was to manage, oversee and drive the key development, review and administration of the pre-market regulatory framework for western medicines. In that capacity, he was mainly responsible for review of product dossiers and market authorization of innovative chemical drugs, generics, biotherapeutics, biosimilars, combination products, vaccines, plasma-derived medicines and advanced therapy medicines. He was also active in regulatory agency consortia such as Australia-Canada-Singapore-Swissmedic (ACSS) consortium and International Generic Drugs Regulators Program on convergence of requirements for market authorization in 16 regulatory agencies including EMA, US FDA, Brazilian ANVISA, Japan PMDA, South Korea MFDS, Mexico COFEPRIS and South Africa MCC. Additionally, he held the positions of Chair of 10 ASEAN Member States’ Pharmaceutical Products Implementation Workgroup, Co-chair of ASEAN drugs and biologics technical working group on harmonization and implementation of medicinal products registration requirements and Temporary Advisor at WHO on Biotherapeutics, Biosimilars, Vaccines and National Regulatory Authority Assessment.
Prior to this, he held several different roles in Industry and Academia for over 20 years in biopharmaceutical manufacturing, QA/QC, GMP, assay development and validation, auditing, clinical reference laboratory, disease diagnostics, and university teaching & research in pathology, parasitology and molecular genetics.
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 certificates in Clinical Trials Management and Healthcare Policy and Governance.