Kevin P. Malobisky is the Senior Director of Regulatory Development and the U.S. Therapeutic Head for Metabolism at sanofi-aventis where he has management and global strategic responsibilities for the development of multiple compounds with indications in metabolism and endocrinology.

In his 18 years of pharmaceutical experience, Mr. Malobisky has participated in the clinical and regulatory development of diagnostic medical devices, biologics, and pharmaceutical drug products. Mr. Malobisky has participated and lead the submission of multiple INDs to numerous divisions at FDA and was responsible for the successful regulatory development and electronic NDA submission of the currently marketed drug product Visicol®(sodium phospate) tablets.

Prior to joining sanofi-aventis, Mr. Malobisky held clinical and regulatory positions with increasing responsibilities at Hoffmann-LaRoche Pharmaceuticals, Roche Molecular Systems, Kendle, Chimeric Therapies, Inc, and InKine Pharmaceuticals. Mr. Malobisky is a member of the Drug Information Association and the Regulatory Affairs Professional Society where he served on the board of editors. In addition, Mr Malobisky has chaired and participated in numerous meetings, conferences, and sessions for RAPS, DIA, PERI, IQPC, and AAPS.

Mr. Malobisky earned a Bachelor of Science degree in microbiology from Penn State University and a Masters degree in QA/RA from Temple University School of Pharmacy where he also serves on the Graduate Steering Committee for the QA/RA Program. Mr. Malobisky also holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society and a paramedic certification from the Pennsylvania State Department of Health.

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