Kristina Haeckl brings over 30 years of experience in global regulatory affairs in the pharmaceutical/biotech industry with demonstrated expertise working for companies with products in all phases of development. In particular, Ms. Haeckl was involved in the key strategic discussions with EMA and FDA to establish current development pathways for antibiotics to fulfill the unmet medical need to address the emergence of infections due to resistant pathogens. Throughout her career, Ms. Haeckl has prepared and submitted many INDs and CTAs in various therapeutic areas and worked on 13 NDAs and many Supplemental NDAs.
Most recently, Ms. Haeckl has provided strategic regulatory guidance under Haeckl Biopharma Consulting, LLC. Previously, Ms. Haeckl was SVP of Regulatory Affairs & Quality Systems at ContraFect Corporation supporting development of a novel class of anti-infective products with a Breakthrough designation. Prior to that, she was one of the initial executives at Zavante Therapeutics (acquired by Nabriva Therapeutics) and held the position of VP of Regulatory Affairs and Quality Systems, establishing the quality systems and successfully negotiating the streamlined development strategy for the CONTEPO™ (fosfomycin for injection) NDA that is currently undergoing review. Ms. Haeckl was on the Executive Management Team at Cerexa (acquired by Allergan) in the position of Executive Director of Regulatory Affairs. While at Cerexa, Ms. Haeckl was instrumental in gaining US marketing approval for AVYCAZ™, as the first product approved under the GAIN Act. Prior to joining Cerexa, she was a member of the Sr. Management Team at MAP Pharmaceuticals responsible for Regulatory Affairs and Quality Systems, establishing the quality systems and directing the company through submission of their first NDA for inhaled dihydroergotamine for acute migraines. Ms. Haeckl’s other regulatory and quality experience includes management positions held at Replidyne, Allos Therapeutics, and OSI Pharmaceuticals (formerly Gilead Sciences and NeXstar Pharmaceuticals) with worldwide regulatory responsibilities for anti-infective and oncology products. She began her career at Syntex USA obtaining increasing responsibility in various roles within their regulatory organization. Ms. Haeckl holds a bachelors degree in Environmental, Population, and Organismic Biology from the University of Colorado at Boulder and has a regulatory affairs certification (RAC).
