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Julia Solarczyk Donnelly

Regulatory Affairs Lead

Julia Solarczyk Donnelly is a regulatory expert with 15+ years of experience managing the creation, review, compilation, and submission of applications and dossiers to regulatory authorities. She has provided regulatory guidance and strategy for numerous clinical research efforts and regulatory applications. Her specialty areas are infectious diseases and vaccine development.

Ms. Donnelly has served as a regulatory affairs team leader at U.S. Army Medical Research and Materiel Command, Fort Detrick, MD. During her tenure of nearly a decade with the U.S. Army, she provided regulatory and technical support for product development efforts for Food and Drug Administration applications sponsored by the Surgeon General–U.S. Department of the Army, including medical product priorities for military emergencies and vaccine trials.

Education

MS, Biomedical Science, with a concentration in Regulatory Compliance, Hood College

BA, Biology, minor in Chemistry, Hood College

Certifications

Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society