Director, Regulatory & Scientific Affairs Policy Term Definition

Regulatory & Scientific Affairs (RSA) provides regulatory guidance for nonclinical studies which include infectious disease related projects to develop vaccines, therapeutics and diagnostics. The incumbent advises the university administration and principal investigators (PI) on scientific and regulatory policy involving strategy in the design and conduct of regulated and non-regulated studies to support development of products designed for the treatment and prevention of human disease for study in clinical trials and may be candidates for licensure. Involved is the design and conduct of both in vitro and in vivo GLP studies that meet scientific and regulatory requirements. The studies are designed to demonstrate vaccine potency, efficacy and safety to prevent disease, implementation of therapeutics to treat infectious disease, definition of antigens that stimulate protective immunity, diagnostic tests to improve clinical medicine, and translation of scientific discovery in the regulatory pathway to product development. Effort is focused on collaborative and programmatic research involving the cooperation of multiple scientific disciplines working together in an environment disciplined by regulatory principles and compliance. (UTMB JD A0401)