AKSHAYA ODAK, Head - Regulatory (Biotech), Lupin

Akshaya S. Odak is currently Head – Regulatory ‐Biotechnology Division of Lupin limited based in Pune, Maharashtra. Prior to that, he was looking after the regulatory function for the registration of Biotechnology products of Wockhardt Limited, Aurangabad. During regulatory tenure, worked primarily on biosimilars and has a vast experience of regulatory dossier filing and product approval in US, EU, Japan, India and more than 70 countries. He has also faced regulatory audits from different agencies viz., US FDA, EU, ANVISA, GCC and other countries. He has an industrial experience of around 29 years and has also worked for companies like Hoechst India Ltd., and Ranbaxy Laboratories Ltd. His prior experience included development and production of Biologics. He has done his Master’s, M.Phil., and Ph.D. from Jiwaji university, Gwalior.