Hilary M Malone, Ph.D., is Chief Regulatory Officer and Head of Global Regulatory Affairs for Sanofi, based in Bridgewater, NJ. In this role, Hilary leads the global, regional and country-based regulatory organization supporting development and marketing, regulatory operations, and manufacturing across Sanofi’s Global Business Units (innovative prescription drugs in primary and specialty care, generic drugs, and consumer health care).
Hilary is a business leader with over 20 years experience in drug development and commercialization in the pharmaceutical industry, with a notable track record in ensuring products are brought to market, navigating regulatory and market access hurdles to optimize revenue growth and profitability. As Global Head of Regulatory Affairs at both Wyeth and Pfizer, she led the regulatory organizations supporting all human health businesses: pharmaceuticals (biologicals, vaccines & small molecules), OTC brands, generics and infant nutritionals. Trained as a PhD. in Neuropharmacology with academic experience, Hilary also worked at SmithKline Beecham/GSK, Astra-Zeneca, and Reata Pharmaceuticals.
Hilary has significant board level and executive committee experience including restructuring/transformation, major M&A, capital raising, investor relations and pre-IPO. Hilary is also a member of the Board of Directors of Inhibikase Therapeutics.