Julia Goldstein

Julia Goldstein is a seasoned Regulatory Affairs Officer with a rich background in the biotechnology sector, boasting a robust history of accomplishments. She brings a wealth of experience in the development of biological products, biomarkers, assay development, and compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Julia has extensive expertise in clinical operations, regulatory compliance for various medical products, especially recombinant proteins and cell products used in autoimmune diseases and transplantation settings. Moreover, her proficiencies extend to the development and evaluation of vaccines, oncology products, and immune modulators in the pharmaceutical industry.

Julia Goldstein pursued her MD in Medicine from the University of Buenos Aires, which laid a strong foundation for her distinguished career in the field of healthcare and biotechnology.

Throughout her career, Julia has held pivotal roles in prestigious organizations such as NIAID-NIH as a Senior Regulatory Affairs Officer, Mediummune as the Director of Regulatory Affairs, SAIC as a Senior Regulatory Affairs Expert Consultant, and the Food and Drug Administration (CBER division) as a Staff Scientist, along with serving as a Staff Fellow at the FDA.