Regulatory Specialist

Summary
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.
This job is open to

• The public
  U.S. Citizens, Nationals or those who owe allegiance to the U.S.

Clarification from the agency
You must be a U.S. Citizen or U.S. National.Foreign nationals or legal permanent residents are not eligible for consideration.This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.
Duties

• Serve as a subject matter expert in Current Good Manufacturing Practices (CGMP) compliance/regulatory issues related to manufacturing of medical products.
• Participates with other FDA Offices, Divisions, and districts on compliance issues and in regulatory meetings to ensure consistency of interpretation of CGMP and collaborates with international regulatory partners to develop and execute compliance programs and actions related to manufacturing quality.
• Collaborate with international regulatory partners to develop and execute compliance programs and actions related to manufacturing quality.
• Serve as a technical scientific lead in one or more major areas and performs substantive work with a multiplicity of unprecedented and complex scientific topics, including, but not limited to: human drugs, adulteration provision of the FD&C Act, emerging technologies, new regulations, and scientific policies.
• Assesses, evaluates, and prioritizes drug compliance issues, and marketed product defects. Informs, consults with, and advises Center and Office management, Office of Regulatory Affairs (ORA), Agency level managers and other multidisciplinary personnel on difficult and complex regulatory, scientific and drug compliance problems and issues discovered during evaluations.
• Provide expert authoritative advice, guidance and recommendations on drug compliance policies, programs, processes, and proceedings as it relates medical products.
• Serve as an authority for often controversial, highly sensitive and complex issues that may have national/international implications (e.g., pharmaceutical ingredient supply chain safety).
• Represents FDA and CDER and participates on internal and external working groups, national tasks force and scientific symposia and public workshops.

Requirements
Conditions of Employment

• 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 Specialistposition which falls under the 0696-00occupational Series, you must meet the following requirements by 11:59 pm EST on 12/04/2023:
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.
Additional information
The application limit, if applicable, for this advertisement is: 500
Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: Yes, 3591
• Telework eligible position: Telework is at the discretion of the supervisor.
• Remote eligible position for highly qualified candidates at the discretion of the supervisor.

• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Additional Information:

• Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• If you are serving, or have served in the last 5 years (from 12/04/2023) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.

All requirements must be met by the closing date of this announcement (12/04/2023); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

• Benefits
  A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
  Eligibility for benefits depends on the type of position y...