Kelene Richardson

Kelene Richardson is a highly experienced regulatory professional with extensive expertise in the pharmaceutical and biopharmaceutical industries. Currently serving as the Director, Global Regulatory Site CMC Lead at Organon since April 2021, Kelene previously held various director-level and management positions at Sanofi from August 2007 to April 2021, overseeing regulatory affairs for a range of products including generic drugs, marketed small molecules, and vaccines. With a robust history of successful FDA interactions and regulatory submissions, Kelene has managed regulatory strategies for 61 Drug Master Files and numerous ANDA and NDA submissions. Prior experience includes roles at Barr Pharmaceuticals, Wyeth Pharmaceuticals, and Bayer Pharmaceuticals, highlighting a strong foundation in compliance, auditing, and quality control. Kelene holds a Master's degree in Business Administration and Management from Fairleigh Dickinson University and a Bachelor's degree in Biochemistry from Manhattan University.