Regulatory Scientific Reviewer (Pharmacist)

Applies expertise in drug formulation, labeling, stability, compounding, drug interactions, and medication use to evaluate the quality, safety, and appropriate use of pharmaceutical products across diverse patient populations. Utilizes knowledge of pharmaceutical sciences and clinical pharmacy practice to support science-based assessments of drug products, manufacturing standards, and medication-related policies. Coordinates assignments with interested parties internal and external to the Agency and integrates it into the broader regulatory programs of the FDA. Advises on area specific research, product specific inspections, or product release responsibilities. Assures that legal and policy considerations are adequately addressed, as well as purely technical matters. Coordinates hearings required in connection with assignments, as appropriate. Serves as an Agency spokesperson and authoritative source of information and advice on matters related to the assigned area of responsibility. D