Robert J. McCormack

Robert J. McCormack, Ph.D., Creative Regulatory Solutions, LLC, Regulatory Consultant. Dr. McCormack has over 30 years in the pharmaceutical sector, and has gained a detailed understanding of drug development, which is substantiated by various positions he has held in the disciplines of nonclinical and clinical research, regulatory affairs and quality assurance. As Vice President of Regulatory Affairs and Quality Assurance at Cubist Pharmaceuticals, Dr. McCormack was responsible for establishing a cross-functional, team-oriented infrastructure in the Clinical, Regulatory, Nonclinical, Manufacturing and Quality Assurance and Control Departments. He acted as primary liaison with FDA/HPB on all issues of strategic importance related to the development of anti-infective compounds. He is providing strategic planning for teixobactin in the areas of nonclinical, clinical, and CMC development, FDA meetings, and IND filings.