Regulatory Counsel

Providing supervision during the ongoing assessment and audits of regulatory matters and quality solutions, such as identifying corrective action plan and/or establishing the appropriate standard operating procedures.

• Overseeing information-gathering, data collection, and fact-finding throughout multiple organizations with affected persons and groups both internal and external.
• Overseeing the complaint process related to the scientific, regulatory, and administrative decisions which impacts the Agency's pending regulatory matters.
• Collaborating with other key personnel during the regulatory decision-making process with a goal towards improving procedures and increasing public confidence in the safety, effectiveness, and quality of biological related products.
• Providing supervision during the ongoing assessment and audits of regulatory matters and quality solutions, such as identifying corrective action plan and/or establishing the appropriate standard operating procedures.
• Leading a variety of substantive activities, such as: receiving and investigating complaints, disagreements, and disputes; providing general information on applicable policies, processes, and procedures

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.
• 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.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.

Qualifications:
In order to qualify for the Regulatory Counsel position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/15/2026:
Basic Qualifications Requirements: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution and/or at least two (2) years of comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products.

Relevant Years of Experience in Lieu of Education: Applicants must meet the following relevant years of experience to qualify for this RC-0301- Band D (GS-14 equivalent) position: seven (7) years of providing analyses and advice on the interpretation of laws, regulations, and policies and guidance applicable for regulated products. Participating or providing leadership in the development, implementation, and evaluation of regulations and policies as they relate to the Agency's programs and activities to ensure the safety, efficacy, and quality of regulated products.

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 (https://www.ed.gov/accreditation) 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. (https://www2.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html)

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:

• National Association of Credential Evaluation Services (NACES) (https://www2.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html)
• Association of International Credentials Evaluators (http://aice-eval.org/members/) (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. (https://www2.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html)

Additional Information:
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: NO
• Telework eligible position: Yes, at the discretion of the supervisor.
• Financial disclosure statement, OGE-450, required: NO

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 authori

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