Colleen Merritt Severyn
Director, Global Regulatory Affairs & Clinical Safety, Merck Research Laboratories (MRL)
Colleen Merritt Severyn currently serves as director, Global Regulatory Affairs and Clinical Safety (GRACS), which is part of Merck’s research and development division. In GRACS, she leads the Business Continuity Initiative and is the architect of the GRACS Innovation Council. Severyn has 17 years of combined project, portfolio, and change management experience as well as product development leadership in the pharmaceutical, biopharmaceutical, and industrial chemical industries. Recently, Severyn served as chief of staff to the senior vice president and head of GRACS. Previously, she provided regulatory submissions management leadership for MRL’s Oncology therapeutic area and worked on multi-indication submissions for KEYTRUDA (pembrolizumab). She also developed and managed the scope and timeline for KEYTRUDA’s core manufacturing team to achieve the timely submission of the company’s Chemistry, Manufacturing and Control (CMC) biologic license application (BLA) to the FDA. In prior years, she worked as an internal change consultant, and led the design and execution of multiple corporate and divisional strategic initiatives. Severyn received a B.S. degree in Chemical Engineering from the University of Maryland and a Ph.D. also in Chemical Engineering from Pennsylvania State University. She is also a certified Sigma Black Belt, Change Execution Management Agent Level 1, Project Management Professional, and Associate Business Continuity Professional.