Vice President, Regulatory Affairs
Irene Figari brings 40 years of biotech experience to the Premier Consulting regulatory affairs team. She spent 16 years in basic research and development, focusing on immunology, cell biology, tumor model systems, and molecular biology, then moved to the regulatory side in roles of increasing responsibility and leadership. She led a team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines in the clinical; nonclinical; and chemistry, manufacturing, and controls arenas. That team delivered regional and international regulatory strategy for pharmaceutical and biotech drug development teams. She has also provided regulatory leadership and development of strategy for products from the pre-investigational new drug (IND) stage through post-marketing in multiple therapeutic areas, with a focus on oncology. A decisive and results-oriented leader recognized for both project and people management, Ms. Figari easily adapts to sudden requests and unforeseen detours. Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast-track applications, pediatric strategies, and marketing applications.