Regulatory Counsel

About the role

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 D (GS-14 equivalent).

Responsibilities

• 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

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.

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

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.