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This position is located in the U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Foods, (OF), Center for Veterinary Medicine (CVM), Rockville, Maryland.
Who May Apply: Open to all United States Citizens.
This announcement may be used to fill additional vacancies.
Conduct scientific reviews of New Animal Drug Applications (NADAs), Master Files (MFs), Investigational New Animal Drug files (INADs) and other related documents such as amendments and supplemental applications for technical information supporting the chemistry, manufacturing and controls of an animal drug product.
Serve as a resource to other chemists, staff, and stakeholders (e.g., other government agencies, general public) in one or more areas related to chemistry (e.g., relating to analytical, medicinal/pharmaceutical or organic chemistry, manufacturing, quality control, metabolism, feed chemistry ).
Determine after evaluation that the manufacturing process and control, raw material and drug testing and specifications and the packaging of animal drugs for pharmaceutical dosage forms and Type A medicated articles provide adequate assurance that the drug products will possess and maintain appropriate chemical and microbiological quality attributes throughout their marketed shelf-life.
Use regulatory knowledge and discretion to ensure review activities are aligned with laws, regulations (e.g., Good Manufacturing Practices), and policies which may require interpretation or adaptation.