Daniela Drago, Ph.D., RAC is an internationally recognized regulatory expert with 15+ years of experience and history of accomplishments in academic institutions as well as the pharmaceutical/biotech industry. She has significant global experience in the development of biologics and new chemical entities in multiple rare and common disease areas including oncology, ophthalmology, infectious diseases, cardiovascular, and neuroscience.

Dr. Drago is currently serving as an Associate Professor at George Washington University’s School of Medicine and Health Sciences. Before joining academia, she has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. Dr. Drago has assisted in the development of numerous FDA-regulated products. She prepared and evaluated hundreds of global regulatory submissions (including INDs, CTAs, NDAs, BLAs, and MAAs), and participated in many meetings with regulatory agencies (including FDA, EMA, MHRA, TGA, BfArM, Anvisa, and Health Canada).

She serves as an expert witness on FDA requirements, global regulatory strategies, and compliance matters.

Currently, she is the Chair of the Regulatory Affairs Professional Society (RAPS) DC/Baltimore Chapter and and an Advisory Council to the Board of Directors of The Organization for Professionals in Regulatory Affairs (TOPRA). Dr. Drago also serves on the board of directors of the Association of Graduate Regulatory Educators (AGRE) and on the Regulatory Affairs Certification Board (RACB). She received her Ph.D. in chemistry from the Swiss Federal Institute of Technology (ETH Zurich).

From News And Events

  • 2019 International Economic Forum

    I am enjoying attending and speaking at the International Economic Forum. I had a great time serving on a session on Innovative Development of the #Pharmaceutical and #Biotech Industry: Keys…

  • 2018 RAPS Convergence in Vancouver

    Thank you Carolina Panico for inviting me to serve as a panelist in the  #RAPS2018 session “The Regulatory Profession: Act II.” Regulatory professionals need to plan what they want to do after…

  • 2018 Summer Institute “Issues and Trends in Regulatory Science”

    From August 20 to August 23, 40 professionals from across the globe attended a four-day multi-disciplinary Summer Institute “Issues and Trends in Regulatory Science.” The institute is hosted by the…

  • Third Russian GMP Conference, Kazan August 27-29, 2018

    It was great to have the opportunity to present at the Third Russian GMP Conference on August 28 in Kazan, Russia. The event was organized by the Ministry of Industry…

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