The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of pharmaceutical quality within CDER, including quality assessment of regulatory submission, manufacturing facility assessment, research, policy development, and surveillance of the quality of marketed pharmaceutical products.
As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. The pharmaceutical scientist performs a full range of duties in one or more of the specialized areas described below, primarily monitoring the lifecycle of both innovator or biological products and generic or biosimilar drugs through a team-based evaluation and assessment of supplements and annual reports using risk management practices.
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