Chief Regulatory /Quality, Atara Biotherapeutics; SVP Regulatory Affairs, Nantworks; SVP Regulatory affairs at Abraxis Bioscience; responsible for global approvals for Abraxane®; regulatory for early stage to post-marketing of nab products; 30+ yrs in international regulatory affairs with Schering AG, FH Faulding/Purepac & APP/Abraxis. Clinical and manufacturing QA, drug safety and clinical operations.