Regulatory Specialist

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of pharmaceutical quality within CDER, including quality assessment of regulatory submission, manufacturing facility assessment, research, policy development, and surveillance of the quality of marketed pharmaceutical products.

The Offices of Pharmaceutical Manufacturing Assessment (OPMA) serves as the OPQ’s centralized resource on manufacturing and facility (including inspection) issues that impact application assessment.

Duties/Responsibilities

As a Regulatory Specialist, the incumbent serves as a subject matter expert (SME) for the inspection/investigation of firms engaged in the manufacture, processing, and control of human pharmaceutical and biologics products to evaluate compliance with the requirements of the Food Drug & Cosmetic Act and the Current Good Manufacturing Practice regulations as it pertains the preapproval and pre-license inspection programs.

• Performs a minimum of two domestic inspections and two international inspections per calendar year.
• Plans, conducts, and directs highly technical, complex, and multi-faceted inspections and in-depth investigations of establishments engaged in the manufacture of biologics, biosimilars, and new and generic human pharmaceuticals.
• Reviews and evaluates comprehensive information and data on the manufacturing process and controls, microbiology controls and sterility assurance, as well as technical product quality microbiology aspects of labeling, and the implementation of the relevant manufacturing control strategy at facilities submitted in Investigational New Drugs (INDs), Drug Master Files (DMFs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental Biologics License Applications (BLAs), NDAs, and ANDAs as appropriate.

Supervisory Responsibilities: N/A

How to Apply

All qualified candidates will submit their cover letter, resume, and transcripts to OPQOPMARecruitment@fda.hhs.gov no later than September 27, 2024.

A resume, not a CV, must be received. You can access the USA Jobs Resume Builder to assist with building your resume.

If you have foreign transcripts, please submit the foreign transcript course-by-course evaluation from an accredited company (NACES or AICE). Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

Please reference Job Reference ID: OPMA Regulatory Specialist in the subject line.

How You Will be Evaluated

Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Announcement Contact

For questions regarding this Cures position, please contact OPQOPMARecruitment@fda.hhs.gov.

The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.