Steve Nava

Stephen Nava joined PACT Pharma in 2023 as the Vice President of CMC Regulatory Affairs and Quality Assurance. Stephen has 30+ years of biotech and pharmaceutical industry experience working in Quality Assurance and Regulatory Affairs. Most recently, he worked as the interim VP of Quality Assurance and Regulatory Affairs for CytomX Therapeutics. Prior to this role, Stephen held the positions of VP of Regulatory Affairs, Compliance, and Quality Assurance, and Head of Quality and CMC Regulatory Affairs at two oncology companies, Sunesis Pharmaceuticals and BiPar Sciences, a wholly owned subsidiary of Sanofi, respectively.

Stephen has extensive experience leading the Regulatory Affairs function including clinical regulatory, CMC regulatory, and Medical Writing. He has extensive expertise in identifying methods to accelerate CMC development, as well as designing and leading the on-time execution of CMC regulatory strategies. Over his career, he has authored and successfully led teams in 30+ INDs/IMPDs and 4 NDAs/MAAs. His prior experience includes both small and large molecules (i.e., monoclonal antibodies (mAb), Antibody-drug conjugates (ADC), Biosimilars, and Bispecific antibodies (bsAbs).