Carmit Nadri-Shay, PhD
VICE PRESIDENT, REGULATORY AFFAIRS
Carmit Nadri-Shay, PhD, holds 15 years of professional regulatory and product development experience across the pharmaceutical industry including small molecules and biologics, with products from early stage through POC and regulatory approvals by multiple health authorities.
Prior to joining Ayala in 2018, Carmit served as Director of Regulatory Affairs at Kamada Ltd. (NASDAQ: KMDA), a biopharmaceutical company focused on developing therapeutic options for orphan indications. At Kamada, Carmit was responsible for regulatory efforts associated with long-term product development of new clinical indications for orphan diseases, which included submissions of SA to the EMA, pre-IND/IND submissions to the FDA, collaborating with KOLs, and submission of Orphan Drug Designation applications. She also ensured global regulatory requirements and strategic planning for the BLA of GLASSIA®, an FDA approved biological drug, in collaboration with the global pharmaceutical company Shire Pharmaceuticals (now Takeda). Carmit also managed the registration dossiers of GLASSIA in ROW countries including Israel, South America, non-EU countries and New-Zealand.
Prior to Kamada Ltd., Carmit served as Senior Manager, Regulatory Affairs at Protalix Biotherapeutics (NYSEAMERICAN: PLX), where she led regulatory product development efforts, including the strategic planning for submissions to the FDA, the Center for Drug Evaluation and Research (CDER) and EMA. Additionally, Carmit maintained the NDA for ELELYSO®, a recombinant orphan drug, which involved collaboration with Pfizer (NYSE: PFE).
Carmit earned her PhD and MMedSc from the Faculty of Health Sciences at Ben Gurion University of the Negev, Israel.