Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Maria Garrigan, as Vice President, Global Regulatory Strategy for the Oncology Business Group (OBG).
In this role, Ms. Garrigan will be responsible for leading the Oncology Regulatory Affairs teams in the United States and United Kingdom. Ms. Garrigan, who joins Eisai with over 20 years of global regulatory experience, will work closely with the company's commercial and OBG strategy organization on the development, planning and management of global regulatory strategies and activities for Eisai's oncology projects. She will provide strategic leadership to the Regulatory Affairs team to ensure the delivery of key objectives.
During her career, Ms. Garrigan has been responsible for the development and implementation of the global regulatory strategies for products in a number of therapeutic areas, including oncology, cardiovascular and gastroenterology. She has led teams in the preparation, coordination and strategy of regulatory submissions to health authorities for the registration and maintenance of new and existing products in the United States and European Union. Ms. Garrigan has also led or supervised meetings with the FDA, as well as planned or participated in meetings with EMA, Health Canada, China's CDE/CFDA and Japan'sPMDA.
"With her vast experience in global regulatory affairs, including nearly a decade focused on oncology, Maria is a very important addition to the Eisai team," said Dr. Alton Kremer, Chief Clinical Officer and Chief Medical Officer, Global Oncology Business Group. "We believe she will play a key role in helping Eisai build its oncology business globally."
Ms. Garrigan joins Eisai from Bayer HealthCare Pharmaceuticals, Inc., where she served as Senior Director, Global Regulatory Affairs, Specialty Medicine, Oncology, since 2013. Her regulatory affairs career began at Berlex, Inc. which was acquired by Bayer in 2006. Ms. Garrigan started her career as a diabetes research scientist at Sandoz, Inc., before joining Berlex, Inc. as a research scientist.