Connie Langer is a Senior Director and leader of the Regulatory Intelligence Team within Pfizer’s Quality Operations and Environmental Health and Safety department. This team performs regulatory surveillance and assesses impact of new and revised regulations on internal processes and provides strategic advice on implementation expectations to key stakeholders at affected sites. Connie collaborates with internal subject matter experts to develop and communicate feedback and Pfizer’s position to health authorities on draft guidance documents and regulations. As a CMC product lead, she acquired extensive experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. Connie is located in Groton, CT and has over 25 years of experience in the pharmaceutical industry. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.