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 1, Band C.
In order to qualify for the Regulatory Specialist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/23/2025: Basic Qualification Requirements: Have 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. OR Have 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: Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates. Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND 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 have 4 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a master's degree and have 3 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have 6 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing.
Reviews recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug and Cosmetic (FD and C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability. Reviews inspection reports submitted by field investigators and other information and data to determine compliance with applicable laws and regulations. Responsible for implementing and managing a full range of compliance actions, both administrative and judicial, including casework and related functional responsibilities in the area of human foods. Provides scientific and technical input on compliance issues and in regulatory meetings to ensure consistency of interpretation of Current Good Manufacturing Practices (CGMPs) and other foods regulations. Leads or participates in cross-functional working groups, regulatory task forces, and agency-wide initiatives focused on enhancing program effectiveness, developing enforcement policies, and improving national compliance outcomes. Evaluates, identifies, and addresses significant problems and issues in areas where nominal policy guidance exists, and requires prompt remediation. Writes technical reports or completes technical analyses based on inspectional and sampling findings of foods and/or dietary supplements and makes recommendations for further action. Provides an accurate assessment of the state of compliance of a firm or corporation on regulatory compliance and enforcement. Perform other duties as assigned.