What are the responsibilities and job description for the Regulatory Counsel position at FDA?
Duties
Summary
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 C.
Requirements
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 07/24/2026: Basic Qualification Requirements: You must have a law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution. OR You must have comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze 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 bachelor's degree and also have four (4) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to FDA-regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of FDA-regulated products. OR Have a master's degree and also have three (3) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a doctorate or a JD degree and also have one (1) year of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a MD/DO/DDS/DPM/DVM degree. OR Have six (6) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. 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 Regulatory Policy (ORP) in Silver Spring, MD. .
Summary
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 C.
Requirements
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 07/24/2026: Basic Qualification Requirements: You must have a law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution. OR You must have comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze 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 bachelor's degree and also have four (4) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to FDA-regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of FDA-regulated products. OR Have a master's degree and also have three (3) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a doctorate or a JD degree and also have one (1) year of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. OR Have a MD/DO/DDS/DPM/DVM degree. OR Have six (6) years of comparable experience providing analyses and advice on the interpretation of laws, regulations, policies, and guidance applicable to regulated products, including participating in or leading the development, implementation, and evaluation of regulations and policies to ensure the safety, efficacy, and quality of regulated products. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. 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 Regulatory Policy (ORP) in Silver Spring, MD. .