With over 23 years of experience in the biopharmaceutical industry, Varma Bhupathiraju is a recognized leader in global regulatory affairs, specializing in the development and approval of biologics. He has played a pivotal role in securing approvals for multiple biological products, including biosimilars and vaccines, across key global markets such as LATAM, MENA, CIS, AFRICA, and APAC. Notably, he pioneered the first-ever US FDA approval for a vaccine candidate from an Indian manufacturer.

Varma has successfully obtained regulatory approvals in over 100 countries and secured GMP accreditations from leading regulatory agencies, including ANVISA-Brazil, COFEPRIS-Mexico, ANMAT-Argentina, ISP-Chile, SAHPRA-South Africa, NPRA-Malaysia, DAV-Vietnam, EDA-Egypt, NAFDAC-Nigeria, TMDA-Tanzania, NDA-Uganda, MCAZ-Zimbabwe, WHO, ensuring alignment to facilitate market access. Additionally, he has been instrumental in streamlining regulatory approval processes in India.

Currently, Varma leads the regulatory team for Emerging Markets and India, driving the company’s mission to expand patient access to affordable biologics.