Nancy McKay

NancyMcKay

Pfizer

Nancy McKay is currently Director of Worldwide Regulatory Strategy at Pfizer, where she manages Regulatory Aspects of Business Development for the Anti-Inflammatory and Immunology space, in addition to her role as regulatory strategic lead for anti-inflammatory / immunologyy programs. She has over 25 years of experience drawn from various areas of Regulatory Affairs, including International, US, development and post marketing areas. She has held worldwide regulatory responsibilities across a number of therapeutic areas (pulmonary, cardiovascular, CNS, oncology, HIV, inflammatory disease, rare diseases, and vaccines), including devices and biologics. She has been involved with interactions with FDA colleagues in therapeutic Divisions and OPDP, for projects and special programs (Critical Path Initiative – Biomarkers, NDA review process, Advertising and Promotion Database, Pulmonary Arterial Hypertension, Pediatric Development). She also has substantial European Regulatory experience, including health authority negotiations worldwide and has been involved in special projects / training with authorities in developing markets. Nancy is an acknowledged Subject Matter Expert in Regulatory Affairs and has been involved in multiple US advisory committees, where she is sought after as a consultant.  She has taught multiple courses in various aspects of US and EU Regulatory Affairs, including a US Regulatory course at the University of Wales.  She currently supports Entrepreneurship Lab NYC (ELab NYC) and ABCT, as a mentor for entrepreneurs starting businesses in the pharmaceutical space around the NYC and CT area.  Nancy has previously worked for Mead Johnson, Bristol Myers Squibb, and Boehringer Ingelheim. She holds degrees in Electrical Engineering and Biomedical Engineering from Vanderbilt University.

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