Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Department of Health and Human Services
The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest Institutes of the National Institutes of Health (NIH), is seeking exceptional and motivated candidates to serve as a regulatory affairs officer within the Office of Regulatory Affairs in the Division of Allergy, Immunology, and Transplantation (DAIT). DAIT supports basic and clinical research to improve our understanding of fundamental immunology and the causes of diseases such as food allergy, atopic dermatitis, asthma, and chronic rhinosinusitis to ultimately develop better diagnostic, treatment, and prevention strategies.
Regulatory affairs officers maintain regulatory and quality assurance surveillance over all clinical trials and protocols supported by DAIT to ensure that trials are conducted in accordance with Food and Drug Administration (FDA) regulations; establish and monitor quality assurance standards and standard operating procedures regarding regulatory matters; review safety reports for DAIT-sponsored trials; act as liaisons for regulatory issues with the FDA, international regulatory authorities, and pharmaceutical companies; and coordinates and communicates with other domestic and international government agencies and with other DAIT components to ensure accurate and timely exchange of information on regulatory issues.
Candidates must be U.S. citizens and demonstrate that they have worked independently in planning, organizing, and conducting biomedical behavioral health or health-related research and served effectively in research program administration in these fields. Experience in pharmaceutical drug development and the preparation of submissions to U.S. and/or international health authorities is preferred.
Visit www.USAJobs.gov and access the health scientist administrator vacancy announcements NIH-GR-DE-19-10594660 (U.S. citizens) and/or NIH-GR-MP-19-10594674 (status candidates) from September 16 through September 25, 2019.