Marisa Dodulik, MS
Associate Director, Regulatory Submissions & Head of Global Regulatory Submissions
Marisa Dodulik, MS is an Associate Director of Regulatory Submissions at Fortrea with more than 20 years of pharmaceutical industry experience supporting global clinical development programs across all phases of drug development. She specializes in U.S. regulatory submissions, overseeing the planning, preparation and execution of high-quality IND applications and amendments to the FDA.
Marisa leads complex submission projects, provides regulatory guidance to cross-functional teams and clients, oversees eCTD publishing through DXC Technology, and serves as U.S. IND agent and primary FDA liaison for sponsors. Prior to joining Fortrea, where she has spent 19 years, she held roles in quality assurance and regulatory submissions at other CROs.
She holds a bachelor’s degree in sociology from The College of New Jersey and has completed a Drug Development Certificate from Temple University and a Women’s Leadership Certificate from Rutgers University.