Alicia Baker McDowell, DRSc, MS, EMBA

Alicia Baker is Vice President and Head of Regulatory Consulting at Fortrea, based in southern New Jersey, with over 30 years of drug development experience, including more than 27 years in global regulatory strategy. She leads a team of experienced product development directors, regulatory strategists, regulatory writers, and patient-centered endpoints experts, supporting nonclinical, clinical, and CMC development, submissions, and global agency interactions, including managing 40–50 agency meetings annually worldwide.

Alicia has registered products in more than 90 countries and has extensive experience engaging directly with global health authorities, including FDA, EMA, MHRA, PMDA, and others. Her experience spans small molecules, biologics, advanced therapies, devices, rare diseases, and expedited development pathways. She holds a BS in biology, two MS degrees in regulatory disciplines, an Executive MBA, and a Doctorate in Regulatory Science