AFDO RAPS Healthcare Products Collaborative
BIO
Connie Langer

Connie

Langer

Regulatory Strategist

Pfizer

Connie Langer is a Director at Pfizer Global Product Development in Groton, Connecticut. She 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. Langer 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, and she’s responsible for new commercial registrations and post-approval maintenance for licenses of pharmaceutical products. Langer co-chairs the International Consortium for Innovation and Quality in Pharmaceutical Development ICH Q12 working group and is a member of the ISPE PQLI® ICH Q12 Working Team. She has a bachelor’s degree in chemical engineering and a master’s degree 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.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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