Kristina Haeckl, RAC

Kristina Haeckl, RAC

Vice President of Regulatory Affairs and Quality Systems

Ms. Haeckl has served as our Vice President of Regulatory Affairs and Quality Systems since June 2020. She brings over 30 years of experience in global regulatory affairs and quality 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.  In particular, Ms. Haeckl has been involved in many key global strategic discussions with FDA and EMA to establish new development pathways for antibiotics to fulfill the unmet medical needs to address the emergence of infections due to resistant pathogens.

Prior to joining ContraFect, Ms. Haeckl was VP of Regulatory Affairs and Quality Systems at Zavante Therapeutics (acquired by Nabriva Therapeutics), where she established the quality systems and successfully negotiated the development strategy for the CONTEPOTM (fosfomycin for injection) NDA.  Ms. Haeckl established her own consulting business in 2015 focused on regulatory expertise and guidance. Prior to establishing her consulting business, Ms. Haeckl was Executive Director of Regulatory Affairs at Cerexa (acquired by Allergan).  While at Cerexa, Ms. Haeckl was responsible for regulatory guidance of the anti-infective franchise and was instrumental in gaining US marketing approval for AVYCAZ™. Prior to joining Cerexa, she was Senior Director of Regulatory Affairs and Quality Systems at MAP Pharmaceuticals.  As head of the regulatory and quality departments, she established the quality systems and directed the company through submission of their first NDA. Prior to joining MAP, she was Director of Regulatory Sciences at Replidyne and established the regulatory, quality assurance, and project management departments. Ms. Haeckl’s other experience includes management positions held at Allos Therapeutics and OSI 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 B.S. in Environmental, Population, and Organismic Biology from the University of Colorado at Boulder and has a Regulatory Affairs Certification (RAC).