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FDA/CDER - Lead Regulatory Counsel - Band E
Food and Drug Administration
| 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 are safe, and effective. The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC). 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 promotion 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 Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products. The Office of Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ will examine current policies, establish new policies, and identify research needs to ensure that drug quality policies support the availability of quality medicines for all Americans. Position Summary: As Lead Regulatory Counsel, the incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy; that their need is justified, and that scientific and regulatory decisions have been appropriately documented. Duties/Responsibilities:
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Professional Experience/Desirable Qualifications AD-301: To meet specialized experience requirements, the applicant’s work experience must have demonstrated the knowledge, skills, and abilities, and competencies necessary to perform at the level of the position. Qualifying experience involves knowledge of federal regulatory programs and possession of a Juris Doctor degree from an accredited institution of higher learning. The education must have been obtained at a college, university, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Conditions of Employment: Security Clearance: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet the requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later. Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action. Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Disclosure Report (OGE 450 or 278) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. |
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