Director Global Regulatory Affairs
Merck & Co., Inc
Seema is currently Director, Global Regulatory Affairs at Merck where she leads regulatory teams in the Oncology TA for investigational and marketed drugs, contributing to regulatory strategy development and execution, including successful approvals. Seema has 20 years of experience in the pharmaceutical industry in multiple therapeutic areas including drug development and regulatory affairs from early through late stage development and registration, with an established track record of successful scientific and regulatory leadership. Prior to Merck, Seema was global regulatory lead at Novartis in the Neuroscience TA, where she was responsible for leading the global regulatory strategy for marketed products and US brand regulatory strategy for Ph II/III investigational drugs. Seema began her industry career at Bristol-Myers Squibb, first in Biopharmaceutics R&D as preformulation / formulation development scientist, and later in Regulatory Affairs for oncology and immunology products.
Seema holds a Bachelor of Pharmacy from University of Pune, India, a M.S in Pharmaceutical Sciences from University of Missouri-Kansas City and a Ph.D. in Pharmaceutical Sciences from Rutgers University.
Monday, September 23
4:00 PM – 5:30 PM