Roger Nosal is currently Vice President of Global Chemistry, Manufacturing & Controls (GCMC) at Pfizer. GCMC is responsible for the development, preparation, prosecution and defense of chemistry, manufacturing and control commitments and data for investigational, commercial and post approval regulatory submissions globally. Roger has been instrumental in developing and establishing Pfizer’s regulatory approach and position for application of Quality by Design, including the introduction of Real Time Release testing (RTRt), Continuous Quality Verification (CQV), Continuous Processing and extension of QbD for development of analytical methods and stability protocols. Roger has 30 years of experience in the pharmaceutical industry at G. D. Searle, Monsanto, Pharmacia and Pfizer. During the last 17 years, Roger has been responsible for developing and executing regulatory CMC strategies and approvals of global commercial applications for 43 new chemical, biological and device products and scores of investigational and post approval regulatory submissions. Prior to his tenure in regulatory, Roger served as a Medicinal Chemist during which he authored 24 patents for a diverse range of medicinal candidates (PAF antagonists, 5-HT3 antagonists & 5-HT4 agonists, COX-2 inhibitors, leukotriene agonists and antagonists, serotonin inhibitors) and as a Process Chemist, where among other projects, he focused on synthetic development and analytical control of derivatives of aspartame and manufacturing optimization of high order cuprate couplings for synthesis of prostaglandins.