Sunita Zalani

Biography

Dr. Zalani joined Intarcia in May 2014 as Vice President, Global Head of Regulatory Affairs and Quality. Dr. Zalani is an experienced regulatory professional with expertise in developing monoclonal antibodies, recombinant proteins and small molecules in multiple therapeutic areas, and has a track record of product approval negotiations with global regulatory agencies. Prior to joining Intarcia, Dr. Zalani was Vice President, Global Regulatory Affairs at Onyx Pharmaceuticals, where she led the regulatory affairs organization and directed the development and execution of global regulatory strategy for pipeline and marketed products in hematology and oncology. Prior to that, Dr. Zalani spent eight years at Amgen, ending her tenure there as Executive Director, Therapeutic Area Head, Global Regulatory Affairs for nephrology, cardiovascular and bone product portfolios. At Amgen, she was a core member of the team executing the development, registration and commercialization strategies for several programs, and provided leadership for global filings, engagement with regulatory agencies, advisory committee meeting preparations and label negotiations to facilitate global regulatory approvals. Prior to that, she was at Eli Lilly and Company for eight years and was responsible for osteoporosis and diabetes product development. There, she provided regulatory support for the global development of several products through various stages of development from IND application to post approval, and she was the regulatory lead responsible for global submissions to facilitate regulatory approvals worldwide. Dr. Zalani conducted her post-doctoral research at the Lineberger Cancer Center in the University of North Carolina at Chapel Hill, and earned her PhD in Biochemistry, and an M.S and B.S from M.S University, India. 

Research Interest

 Her research interest in Biochemistry