AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis

•   Amita Bhave, is Heading Regulatory Affairs, GDD India and is working with Novartis for more than 10 years. She had earlier handled added responsibility as head RA BoE in Hyderabad serving AMAC/ LACan countries.

•   Amita has overall 20+ years’ experience in Indian Pharma industry earlier in multiple domains of Medical support, Clinical Operations, Regulatory Affairs.

•   Amita has a huge experience of handling New drug applications, Import registrations, clinical trial applications and regulatory compliance and is instrumental is designing regulatory strategy for Novartis pipeline products.

•   Amita is well connected in Indian pharma industry and Indian regulators’ office. She is an active member of Associations like OPPI in Medical- regulatory committee and was co-chair of ISCR regulatory council. She is also regular contributor as author to a peer reviewed journals and has various publications in well reputed journals. Amita has been guest invitee as speaker/ panelists in Industry forums.

•   Amita has been honorary faculty at NMIMS University, Mumbai. She delivers guess lectures on Regulatory Affairs subject for curriculum of Executive MBA in Pharma Management.