Deputy Office Director; Supervisory Regulatory Specialist

This position is being filled under a streamlined 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

F. In order to qualify for the Deputy Office Director (Supervisory Regulatory Specialist) position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/24/2026.

• 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.
• Have a minimum of eleven (11) years of 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.

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 seven (7) years of 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 areas: 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.
• Have a master's degree and also have six (6) years of 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 areas: 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.
• Have a Doctorate and/or J.D. degree and also have four (4) years of 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 areas: 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.
• Have an MD, DO, DDS, DPM, or DVM degree and also have four (4) years of comparable regulatory experience or…