SVP & Head of Regulatory Affairs
Susan Franks brings over 30 years of Regulatory and Project Management experience in the pharmaceutical industry from Wyeth, Premier Research Group, Cephalon and Teva Pharmaceuticals. At Braeburn, Susan heads the Regulatory Affairs function, driving regulatory strategies to optimize outcomes for Braeburn’s portfolio of drug products, as well as ensuring full adherence with FDA regulations for products in IND stage through NDA filing and beyond. Most recently, Susan led a large Global Regulatory organization for Teva’s Specialty portfolio of over 40 drug projects in global markets across multiple therapeutic areas, and previously focused in the areas of Pain and Infectious Disease. In the Pain/Opioid space, Susan led the successful registration of Exalgo® (hydromorphone extended release) and Vantrela® ER (hydrocodone), as well as managed FDA negotiations for a complex post-approval REMS program for Fentora® and Actiq (immediate release fentanyl products).