This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/2... view the full vacancy announcement, click here: https://www.fda.gov/media/167425/downloadIntroductionThe 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 safe, and effective.The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.The mission of the Office of Compliance (OC) is to shield the public from poor-quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER Compliance strives to be a model of efficiency, innovation, and organizational excellence. CDER Compliance makes strategic and risk-based decisions that are guided by law and science to communicate clearly with stakeholders, foster global collaboration, promote voluntary compliance, and take decisive action.Duties/ResponsibilitiesAs the Deputy Super Office Director (Supervisory Regulatory Counsel), reporting to the Deputy Director of the Office of Compliance (CDER OC), the incumbent will share the responsibility for the management and direction of a multi-disciplinary staff of more than 400 scientific and regulatory professionals engaged in planning, executing, and administering a broad range of national programs related to protecting the health of patients and consumers from risks associated with violations of federal drug law and regulation.Responsible for the development and implementation of proactive and risk-based compliance and enforcement strategies and actions that are patient-focused and risk-based to secure the safety, efficacy, and quality of the nation’s drug supply.Strategically oversees and implements FDA and Center compliance programs and projects to identify, assess, and prioritize the public health significance of legal violations presented throughout the drug lifecycle. Develops and implements innovative enforcement strategies and risk-based decision-making to reduce public health risk by ensuring that marketed drugs are of high quality and integrity, properly labeled, safe, pure, and meet applicable drug approval requirements.Develops comprehensive policy and procedural guidelines for handling legal actions related to human drugs. Reviews and approves legal approaches and actions in cases, particularly those that are controversial, precedent setting, or otherwise significant cases.Represents the Director/Office in meetings, discussions, and conferences with senior Agency and Departmental officials, regulated industry representatives, the medical, scientific, and academic communities, national and international scientific and health related professional organizations, Congress, and representatives from other Federal, state, local and international governmental agencies to present and explain Office activities, actions, plans, and policies.Serves as the lead on special projects and activities of interest and concern to the Office Director that involve sensitive and controversial problems, issues, or actions related to policy and/or program matters which may result from a public health emergency or may have congressional interest.Supervisory Responsibilities:Manages one or more portfolios and provides leadership and direction for multiple, smaller program offices in coordination with the Super Office Director. Directly supervises the Super Office’s Senior Medical Officer and Senior Program Manager. Shares responsibility with the Super Office Director to provide overall program direction to subordinate Sub-Offices and Divisions and through the responsible managers of these Offices and Divisions. Provides direction to a budgeted staff of 436 employees including scientific, medical, legal, professional, technical, administrative, and clerical personnel ranging in pay scale from Titles 42 and GS 15 Supervisory positions to entry levels, as well as scientists and physicians hired under Title 42 and Title 38.How to ApplyAll qualified candidates should submit their resume with cover letter and transcripts in PDF format by May 5, 2023, to: FDACDEROC_Recruit@fda.hhs.gov. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share.”For questions, please submit your inquiry with email subject title “CDER-OC-Deputy Super Office Director” when applying or submitting questions.Announcement ContactFor questions regarding this Cures position, please contact FDACDEROC_Recruit@fda.hhs.gov.The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.FDA is an equal opportunity employer.