Kathryn Regiec
About Kathryn Regiec
Kathryn Regiec is a Submission Manager at Bristol-Myers Squibb with extensive experience in clinical research and regulatory practices.
Company
Kathryn Regiec is currently employed at Bristol-Myers Squibb in Lawrenceville, NJ. She serves as a Submission Manager, utilizing her extensive experience in the clinical research and regulatory submission field.
Title
Kathryn Regiec holds the position of Submission Manager at Bristol-Myers Squibb. In this role, she applies her skills in managing and submitting clinical documents, regulatory dossiers, and other related tasks.
Education and Expertise
Kathryn Regiec earned a Master of Public Health (MPH) with a focus on Epidemiology and Global Health from the University of South Florida between 2008 and 2010. Prior to that, she obtained a Bachelor of Science (BS) in Biobehavioral Health from Pennsylvania State University, completing her studies there from 2004 to 2007.
Background
Kathryn Regiec's career includes significant roles in clinical and regulatory functions. She worked at Novo Nordisk as a Clinical Trial Associate from 2014 to 2016 and earlier as a Clinical Publishing Associate in 2016. Before Novo Nordisk, she spent three years as Global Site Services Associate at Covance from 2011 to 2014. Previous roles include a Tuberculosis Prevention and Control Intern at the Pan American Health Organization in 2010 and an Undergraduate Research Assistant at Penn State University in 2007.
Achievements
Throughout her career, Kathryn Regiec has developed expertise in managing clinical research across various therapeutic areas, including Diabetes, Idiopathic Pulmonary Fibrosis, and Oncology. She has experience negotiating site contracts, reviewing trial master files, preparing clinical documents, and guiding new team members on regulatory submissions. This experience is supported by a global regulatory perspective, honed through participation in programs like the Semester at Sea.