Lenore Faulhaber

Lenore Faulhaber

Principle Scientist, Global Product Stewardship, Procter & Gamble

Lenore has over fifteen years of hands-on regulatory experience in both the pharmaceutical and medical device fields. She has successfully managed and executed IND, NDA and 510(k) submissions and has experience in guiding both pharmaceutical and medical device project teams to ensure regulatory compliance and successful FDA interactions. Lenore has developed internal regulatory guidance documents, SOPs, and has trained personnel to assure compliance. She has worked closely with QA organizations in hosting FDA audits to successful outcomes and has provided industry opinions to be considered in public comment to proposed regulations. Lenore holds a Ph.D. in Biological Sciences from the University of Cincinnati and an M.B.A. from the University of Cincinnati