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The Office of Regulatory Affairs (ORA) is the lead office for all Food and Drug Administration (FDA) Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA Supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
WHO MAY APPLY: This vacancy is only open to current permanent employees of the Food and Drug Administration (FDA) with competitive status. Competitive status refers to employees who are serving on a career or career-conditional appointment.
YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action) to document status.
FDA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred as (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
The salary listed in the vacancy announcement includes the geographical locality pay.
These positions are located in the Food and Drug Administration, Office of Regulatory Affairs, Southeast Region, Atlanta District Office, with duty stations in Atlanta, GA and Raleigh, NC.
This announcement may be used to fill multiple positions in multiple location
The position is located in the FDA district office or resident post and represents the highest level of expertise for the inspection of firms engaged in the manufacture, processing and control of human or veterinary pharmaceutical products, for compliance with FDA laws and regulations.
Assignments will involve inspections/investigations across the district. As a Program Manager, the incumbent is a primary source of expertise in the assigned geographic area who resolves the most difficult, controversial and complex inspectional problems which involve a combination of scientific and regulatory responsibilities.
- Plan, conduct, and direct highly technical, complex and multi-faceted inspections and in-depth investigations.
- Provide extensive advisory, liaison and consultative services for drug programs to regulated industries, State agencies, other Federal agencies and Agency management.
- Manage the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety criteria.
- Research and prepare final background and decision papers for the signature of the Director.
- Serve on task forces and study groups charged with considering problems or directions in the area of expertise.
- Conduct inspections of both domestic and international pharmaceutical establishments.