Paula Strauss-Levy, a Regulatory-Affairs and Clinical-Development expert, is joining DRA as VP of Pharmaceuticals. Paula has over 20 years of experience in the pharmaceutical industry, serving in different positions, including VP, Clinical and Regulatory Development, VP, Clinical and IP, Board member, Senior Regulatory and Scientific Affairs Director, Market Access Director, and more. Paula has extensive Regulatory expertise with US-FDA, EMA, European Competent authorities, TGA, Health Canada, MHRA, IMOH, ANVISA, and others which translates into a variety of deliverables such as MAAs, BLAs/ NDAs, Scientific Advice, pre-IND, pre-BLA/NDA, pre-MAA, PIP, ITF meetings, FDA/ EMA Parallel Scientific Advice, EUnetHTA meetings, as well as specialty designations such as ODDs, PRIME/ Breakthrough Designation, Rare Pediatric Disease Designation Request, Fast Track, Accelerated Approval, SMEs, Innovative Licensing and Access Pathway and Promising Innovative Medicines (MHRA) and other.
Paula’s expertise includes additional critical drug development disciplines such as Clinical Research, Intellectual Property, Market Access, Medical Writing, and Due Diligence.
Paula has been actively involved in IPO processes, Roadshows, M&As, and different business transactions within the pharma industry, which enables her to provide our clients a holistic, 360-view of their development process, bearing in mind time-to-market, ROI, and avoiding any potential blind spots.
Paula has an MBA from the British University of Derby and a B.Sc in Biochemistry and Food Sciences from the Hebrew University of Jerusalem.
Born in Ukraine, lives in Madrid, mother of two children, a husky, and two cats.