DutiesSummaryThis 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 E.
RequirementsQualificationsIntroduction: 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 Counsel position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/28/2024: Minimal Qualifications Requirements for the Regulatory Counsel, AD-0301-00 Education: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution. -OR- Comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products. In addition, to qualify for the Band E level, applicants must meet the qualification requirements below. Law degree, specifically a LL.M. or J.D. degree and also have 3 years of relevant experience in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies. OR 9 years of relevant experience in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum/Education Requirements.
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), Office of the Commissioner (OC), Office of Policy, Legislation, and International Affairs (OPLIA), Office of Policy (OP), Silver Spring, Maryland. Office of Policy (OP) is responsible for high-priority, complex, regulatory policy development, and coordination, as well as operational activities that support policy development across FDA.