Current Job and Project Opportunities
Posting: #FDAAA 18-028
Job/Opportunity: Director, Office of Regulatory Policy
Organization: Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)
The Center for Drug Evaluation and Research (CDER) located at the Food and Drug Administration (FDA) in Silver Spring, MD is recruiting to fill the position of Director, Office of Regulatory Policy. FDA is a Federal scientific, regulatory, and law enforcement agency with the statutory responsibility to promote and protect the health of the American public. FDA’s programs are national in scope and effect, and its activities directly affect and heavily impact multi-billion-dollar industries and every American.
CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Regulatory Policy (ORP) provides Center oversight and leadership in the development of regulations, policies, procedures, and guidances that pertain to the drug approval process. ORP’s oversight extends to the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and FDA’s public disclosure regulations. The Director of ORP reports directly to the CDER Deputy Center Director for Regulatory Policy.
Posting Date: 9/18