Ruth Hill

Ruth Hill, RAC is our Regulatory Affairs consultant with over 27 years of industry experience developing and implementing regulatory and product development strategies for a variety of dosage forms at all stages of development in a wide variety of therapeutic areas. Ruth is currently the Senior Regulatory Affairs Officer at BioPharma Global where she leads key regulatory projects providing a wide variety of regulatory consulting services to small and large companies in the pharmaceutical industry. Ruth has authored more than 35 INDs, 18 CTDs (NDA, BLA, and ANDA), and 50 Post Approval Supplements in a wide variety of therapeutic areas, such as oncology, neurology, dermatology, pulmonology, and analgesia, as well as therapies in the orphan drug and rare disease space. In addition, Ruth has decades of experience in negotiation with regulatory agencies, risk assessments for development strategies, and CMC and cGMP regulatory compliance.

Although Ruth has developed a broad base of experience throughout her career, Ruth’s area of expertise has consistently been the development of the pharmaceutical itself (also known as CMC), the FDA regulations supporting that development (also known as CMC regulatory), and the preparation of those portions of the regulatory submissions supporting that pharmaceutical development. She has held management-level positions in regulatory departments at biotechnology companies including, Mayne Pharma (Vice President of Regulatory and Medical Affairs), Perrigo Company (Head of Regulatory Affairs), Synthon Pharmaceuticals (Senior Director, Regulatory Affairs), and UCB Pharma (US Head of CMC Regulatory Affairs).