Deputy Office Director (Supervisory Regulatory Specialist)
What you'd do
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band F.
Major duties
Provides assistance to the Office of Drug Security, Integrity, and Response (ODSIR) Director in the management and direction of the development and implementation of the Agency's human drug import, export, recalls, and supply chain integrity compliance and enforcement programs. Supports the ODSIR Director in development and oversight of policy implementation, surveillance activities, compliance strategies, regulatory actions and enforcement actions pertaining to the Drug Supply Chain Security Act (DSCSA); Drug imports and recalls under the Federal Food, Drug, and Cosmetic Act and other applicable laws and regulations; and FDA Export Reform and Enhancement Act of 1996 for drugs, by providing export certificates for legal export of drugs from the U.S. Manages and coordinates operational issues pertaining to drug recalls and shortages for the Office of Compliance, including coordination of consults from FDA's Drug Shortages Staff, as well as compliance evaluation and actions by the Office of Compliance's Office of Manufacturing Quality and Office of Inspections and Investigations (OII) Field Offices. Provides leadership within the of Office of Compliance for incident response to urgent, emerging, and evolving public health issues related to FDA approved drugs, counterfeit and substandard drugs, and other unapproved drug products. Provides direction to the Division of Supply Chain Integrity, coordinating Office of Compliance efforts to investigate and evaluate incidents to contain the public health exposure to potentially harmful drugs. Works closely with other CDER Offices, including CDER's Counterterrorism and Emergency Coordination Staff, as well as the Agency's Office of Emergency Operations. Supports the development of comprehensive policy and procedural guidelines for handling compliance and enforcement actions related to human drugs. Coordinates Center and OII Field relations and provides support and guidance to field offices on case development, evaluations, and regulatory actions, and ensures uniform interpretation and application of standards. Represents the Center in meetings with top level representatives of other Federal and State agencies to obtain their cooperation on compliance matters of mutual interest. Engages with stakeholders, including top level leaders of regulated industries, to promote compliance. Represents the ODSIR Director in meetings with the Commissioner and other senior Agency officials on compliance matters of major significance.
What you need to qualify
In order to qualify for the Deputy Office Director (Supervisory Regulatory Specialist) position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/24/2026: Basic Qualification Requirements: A bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution. -OR- Have a minimum of eleven (11) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. AND RELEVANT YEARS OF EXPERIENCE: IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and also have seven (7) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. OR, Have a master's degree and also have six (6) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. OR, Have a Doctorate and/or J.D. degree and also have four (4) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. OR, Have a MD, DO, DDS, DPM, or DVM degree and also have four (4) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. OR, Have eleven (11) years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; product development, process development, scale-up, or commercial manufacturing; sterility assurance and microbiological controls. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Before you apply
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