Deputy Office Director (Supervisory Regulatory Counsel)

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 2, Band F. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

• 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), including the development, implementation, and oversight of federal Good Distribution Practice standards; drug imports and recalls under the Federal Food, Drug, and Cosmetic Act and other applicable laws and regulations; and the 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 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.

In order to qualify for the Deputy Office Director (Supervisory Regulatory Counsel) position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/24/2026:

Basic Qualification Requirements: A law degree, specifically an LL.M. or J.D. The degree must be from an accredited program or institution.

-OR-

Have a minimum of eleven (11) years of comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or developing or analyzing regulations and policies for regulated products.

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 law degree, specifically an LL.M. or J.D., and also have four (4) years of comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or developing or analyzing regulations and policies for regulated products.
OR,
Have eleven (11) years of comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or developing or analyzing regulations and policies for regulated products.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.