Ruth Hill is an industry leading expert in Regulatory Affairs with over 30 years of experience in the human and animal health industry. A Regulatory Affairs Certified (RAC) professional with a complex understanding on how to properly develop and implement regulatory and product development strategies for a wide array of veterinary and human dosage applications, including orals, topicals, and injectables, throughout all development stages. Ruth has extensive background in therapeutics and has authored more than 35 INDs, 18 CTDs, and 50 post approval supplements. Ruth has participated in numerous meetings with key opinion leaders and government officials to ensure project goals are met and structure a KOL network that is in line with current product needs. She has also led cross functional departmental teams to implement regulatory strategies, provide input to business development due diligence and portfolio selection and provide training companywide in regulatory affairs.
Ruth has extensive experience in managing cross functional teams and dealing with global regulatory agencies to meet strict timelines while meeting strict quality and safety standards. She has decades of experience negotiating with the FDA to reach milestones and timely approvals for both new prescription drug products and generic drug products. She is skilled in drafting dossiers, planning submissions, and managing negotiations with global regulatory agencies to promote a positive financial and timely outcome for clients.
Ruth has held management level positions with Mayne Pharma Inc, Perrigo Company, Synthon Pharmaceuticals, and UCB Pharma. More recently she has served as an independent consultant in the Pharmaceutical Regulatory space.
Ruth holds a Bachelor of Science in Biology from Meredith College.