Lilla Szokol-Borsodi

Prepare, submit and maintaine CTAs to European and international Health Authorities (HAs) in accordance with the applicable regulatory requirements; provide regulatory input and guidance for clinical trials and their submission to European and international HAs; liaise with internal personnel or CRO to request and collect appropriate documents and arrange submission; interact with HAs or other parties regarding CTAs; ensure proper running of the trial during its life cycle from a regulatory perspective

Clinical Trial Application submission to Regulatory Authority in Hungary, I have been supporting provision of PAREXEL’s regulatory services, coordinating international clinical trials as a Functional Lead for a US pharmaceutical company, and providing regulatory support and guidance on multidisciplinary Project Teams.

Administrative assistant at the Department of Clinical Trial Regulatory Services, PAREXEL, Hungary. During this period, I was performing not only administrative tasks but was involved in the local Clinical Trial Application submission processes to gain experience in regulatory affairs.

Working with in vitro plant cell cultures to produce anti-cancer agents.