Mr. Sekhar Ponuganti is a pharmaceutical and biopharmaceutical professional with extensive experience spanning manufacturing, biologics, project management, regulatory affairs, and global product lifecycle management. He completed his master’s in biotechnology and began his career in vaccine manufacturing, gaining strong foundations in regulated pharmaceutical operations.

He subsequently worked with biologics CDMOs in upstream manufacturing, contributing to the successful EMA approval of a monoclonal antibody. His experience expanded into SAP implementation across biologics CDMO operations and manufacturing planning, followed by project management roles within biologics CDMOs and product manufacturing organizations.

As a Project Manager, Sekhar has managed complex global projects involving clients across the US, Europe, Latin America, Russia, and the Middle East, with extensive exposure to client and regulatory agency audits. His regulatory experience includes interactions and project involvement with agencies such as ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), and ISP (Chile).

He later led Regulatory Affairs for a major Marketing Authorization Transfer project involving more than 400 registrations across 120 countries. Currently, Sekhar leads the global Insulin and Analogue regulatory team covering APAC, LATAM, AFMET, US, Canada, Europe, and Australia, with a focus on regulatory strategy, product lifecycle management, market access, and ensuring uninterrupted supply of critical medicines.