The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). This position is being filled under a streamlined hiring authority, 21 US Code 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

Duties

Performs substantive activities in major critical compliance areas that includes involving difficult, complex, controversial, and precedent setting quality evaluations; guidance and policy development; international agreements; inspections; surveillance evaluation; drug recall evaluation; and manufacturing shortage mitigation. Provides coordination within the Office of Manufacturing Quality (OMQ) to whom all levels of staff may turn to for consultative guidance regarding inspection and investigation methods necessary to manage regulatory and compliance actions. Provides substantive technical scientific coordination within OMQ on all significant issues related to drug manufacturing and assesses medical products as it pertains to OMQ's compliance program. Demonstrates expertise in the biological sciences, and an understanding of supply chain issues and current good manufacturing practices (CGMPs). Conducts scientific reviews of biochemical and manufacturing science data for scientific or regulatory issues involving medical products that may be in shortage or have the potential for shortage and evaluates the results. Prepares comprehensive summaries and integrated discussions of scientific data submitted for review and other available information. Submits regulatory recommendations and conclusions for concurrence by senior scientific staff and writes comprehensive analytical reports from scientific investigations studies and projects. Reviews and evaluates regulatory discretion submissions to determine whether the data submitted warrants consideration of enforcement discretion. Prepares data and information gathered during inspections and investigations and conducts informational hearings with non- compliant establishments. Reviews, evaluates and prepares proposed legal actions to ascertain conformance with enforcement policy, regulatory objectives, jurisdiction, and adequacy of evidence.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.

Qualifications

Introduction: The 21st Century Cures Act ("Cures" or The Act) grants the HHS/FDA the authority to appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service. Candidates will be appointed and compensated without regard to Title 5 of the United States Code (U.S.C.) governing appointment in the competitive service. The Act further states the Commissioner of FDA may determine and set (1) the annual rate of pay of any individual appointed; (2) the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position before the date of enactment of the 21st Century Cures Act. Based on the Act, it allows the FDA the authority to create and administer its own Alternative Pay System (APS) to recruit and retain qualified scientific, technical, or professional candidates to carry out mission-critical functions. In order to qualify for the Regulatory Specialist position which falls under the 0696-00 occupational Series, you must meet the following requirements by 11:59 pm EST on 12/01/2023: In order to qualify for a Regulatory Specialist, AD-0696-00, you must meet the following: Basic Qualification Requirements: Education: 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. (Unofficial transcripts are required that reflect your degree type, major, and date degree was conferred.) -- OR - 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: (1) Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; (2) Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; (3) Product development, process development, scale-up, or commercial manufacturing; and/or, (4) Sterility assurance and microbiological controls. NOTE: Applicants who qualify based on the education must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum Qualifications.

Education

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.

See the Application Manager Documentation for tips on submitting your paper-based documents.

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.

Contacts

• Address FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]