Rob Kowalski is currently the Head of Regulatory Affairs for Novartis and the US Head of Global Drug Development, based in East Hanover, New Jersey, USA.
Rob is a senior drug development and regulatory executive with over 25 years of industry experience. Rob and his teams have successfully developed and registered over 100 new chemical entities, new indications, and devices across a wide array of therapeutic areas in the small molecule, biologics, biosimilar, and cell and gene therapy spaces.
In addition to being an active member in multiple professional organizations, Rob is the past-Chair of PhRMA’s Regulatory Affairs Committee and Vice-Chairman of the Board of Directors for the R&D Council of New Jersey. Rob was a member of the FDA Rare Disease Advisory Panel and an industry representative for PDUFA 5, 6, and 7 FDA reauthorization negotiations. He is also a founding member of the Industry Pharmacists Organization Advisory Board and a past-member of the TOPRA Advisory Council.
Rob held past regulatory leadership roles at Pharmacia (now Pfizer) and Schering-Plough (now Merck). He has also previously served as the Global Head of Development Medical Affairs for Novartis. Rob attended the University of Wisconsin–Madison where he received both a Bachelor of Science in Pharmaceutical Sciences and a Doctorate in Pharmacy. Rob completed his post-doctoral training at Rutgers University/Sandoz Pharmaceuticals and has trained at the Executive Forum of the Harvard Business School.