Regulatory Specialist

Full Job Description

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 03/25/2026: Basic Qualification Requirements: 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 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: 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 IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. 1.

Have a bachelor's degree and also have four (4) years of comparable experience in the following: 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.

2.

Have a master's degree and also have three (3) years of comparable experience in the following: 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.

3. Have a Doctorate and/or J.D.

degree and also have one (1) year of comparable experience in the following: 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.

4.. Have a MD, DO, DDS, DPM, or DVM degree. 5.

Possess six (6) years of comparable experience in the following: 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. Major Duties:

Conducts reactive post market quality-based assessments of complex facilities and products by identifying, evaluating, and trending quality intelligence, such as post market defect reports, laboratory testing results, and drug amount reporting, to execute response actions that mitigate urgent quality issues and risks associated with pharmaceutical formulation and manufacturing processes.

Participates in or leads routine inspections, pre-operational activities, or quality management maturity assessments, as necessary.

Performs complex quality surveillance activities to characterize the state of pharmaceutical quality and proactively manage risks affecting product quality and availability through facility and product assessments.

Informs risk-based prioritization of quality surveillance assignments, such as sampling and testing, inspections, or investigations.

Reviews and evaluates submissions for drug and biologics manufacturing processes and facilities to assess the adequacy of pharmaceutical manufacturing design and understanding, as well as process monitoring, control, and scale-up strategies.

For biologics and sterile drug substances, and sterile drug products, this includes product packaging integrity, cross-contamination prevention, microbiology product quality and sterility assurance, and technical product quality microbiology aspects of labeling.

Reviews and evaluates inspection and investigation evidence and findings indicating a possible lack of compliance with Agency enforcement laws and regulation, including as they pertain to the pre-approval and pre-license inspection compliance programs, or potential issues with drug manufacturing and product quality.

Serves as the regulatory manager/coordinator for an assigned group of drug/biological products or office level program.

Activities may include management (coordination, fact-finding, etc.) of applications from investigational stage through marketing application review, and post-marketing quality oversight.

Establishes and implements all goals, deadlines, and other metrics specified in the applicable User Fee Act (UFA), laws/statue, regulations, and internal procedures are met for assigned projects.

Serves as the primary point-of-contact with regulated industry for all issues related to the status of applications or office level programs.