Connie Langer is a Director at Pfizer Global Product Development in Groton, Connecticut. Connie has a BS in chemical engineering and an MS in oceanography from the University of Connecticut and a drug development certificate from the School of Pharmacy, Quality Assurance and Regulatory Affairs at Temple University. Connie joined Pfizer in 1998 as a scientist in the Pharmacokinetics, Dynamics, and Metabolism Department, where she employed quantitative and qualitative mass spectrometry techniques to study drug metabolism, biopharmaceutics, and the environmental fate and effects of pharmaceuticals. She is currently a regulatory strategist in the Global CMC department, managing and executing life-cycle CMC regulatory activities, providing global strategy and regulatory submissions for investigational studies, new commercial registrations, and post approval maintenance for licenses of pharmaceutical products. Connie co-chairs the International Consortium for Innovation and Quality in Pharmaceutical Development ICH Q12 working group and is a member of ISPE PQLI® ICH Q12 Working Team.