Ramola Bhandarkar

Ramola Bhandarkar

Senior Vice President, Regulatory Affairs

Ramola Bhandarkar brings significant experience working with a diverse range of therapeutics including cellular therapies, monoclonal antibodies, antibody-drug conjugates, and small molecules.

Most recently, Ms. Bhandarkar was the Head of Regulatory Strategy for bluebird bio’s Oncology Business Unit and contributed toward building that team. She was responsible for providing strategic regulatory expertise for both early and late phase cellular therapy and gene-edited programs. During her time at bluebird bio, she was the bluebird bio Global Regulatory Lead for ABECMA®, which earned the distinction of becoming the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. Prior to bluebird bio, Ms. Bhandarkar held positions of increasing responsibility at ImmunoGen, Inc. where she led the clinical regulatory group which provided regulatory guidance for a number of early and late phase antibody-drug conjugates to treat cancer. Earlier in her career, Ms. Bhandarkar spent many years at Cephalon (now Teva Pharmaceuticals) and Organon, Inc. in pharmaceutical development.

Ms. Bhandarkar received her M.S. in Quality Assurance/Regulatory Affairs from Temple University, her M.S. in Pharmaceutical Sciences from University of Missouri-Kansas City and her Bachelor of Pharmacy from Pune University, India.

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