Kristina Haeckl

Vice President of Regulatory Affairs and Quality Systems

Kristina Haeckl, RAC, currently serves as vice president of regulatory affairs and quality systems at Zavante Therapeutics. She brings more than 25 years of experience in global regulatory affairs in the pharmaceutical industry with demonstrated expertise working for large, mid-size and small start-up pharmaceutical companies with products in all phases of development. Haeckl previously provided regulatory expertise to Zavante through her consulting business, Haeckl Biopharma Consulting. She previously served on the executive management team at Cerexa in the position of executive director of regulatory affairs and was responsible for the anti-infective programs and was instrumental in gaining U.S. marketing approval for AVYCAZ™. Prior to joining Cerexa, Haeckl was senior director of regulatory affairs and quality systems at MAP Pharmaceuticals, where she established the quality systems and directed the company through submission of their first NDA. Prior to joining MAP, Haeckl was director of regulatory sciences at Replidyne, and established the regulatory, quality assurance and project management departments. Her other experience includes management positions held at OSI Pharmaceuticals (formerly Gilead Sciences and NeXstar Pharmaceuticals) and Allos Therapeutics, working on global programs for anti-infective and oncology products. She began her career at Syntex USA obtaining increasing responsibility in various roles within the regulatory organization. Haeckl holds a bachelor’s degree in environmental, population and organismic biology from the University of Colorado at Boulder and has a regulatory affairs certification (RAC).