description Summary

Girija Kelath currently heads Global Regulatory science team for Small molecule APIs and Generic Formulations at Biocon Limited. She has more than 25 years of experience in Pharmaceutical industry. Girija Joined Biocon in 2002 as Deputy Manager, Regulatory and eventually grew to Head Regulatory science team. In this role, she heads the team dedicated for registration of Drug substance, Drug products for the global market, customer/partner communication, communication/meeting with Regulatory Agencies, ensuring regulatory compliance from development stage to registration of drug products, Life cycle management of products, playing a key role in strategic decisions, keep up to date with ever changing international guidelines and customer practices.

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