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 the 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 human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.

The Office of Quality Surveillance (OQS) is OPQ’s focal point to assure that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.

Duties/Responsibilities

As a Regulatory Specialist, the incumbent provides authoritative guidance and consultation regarding current good manufacturing practices (CGMPs) for pharmaceutical manufacturing in the context of on-site inspections; and supports the human drug surveillance program through qualitative and quantitative regulatory assessments quality management maturity, pharmaceutical quality system effectiveness, and other related quality intelligence available throughout the product lifecycle.

• Evaluates records of from pharmaceutical manufacturing sites to determine compliance with CGMPs and recommends appropriate follow-up surveillance or compliance actions.
• Assesses site inspection reports completed by foreign regulatory partners.
• Conducts post-market quality-based assessments of manufacturing sites and products by identifying and evaluating trending quality intelligence to execute response actions that mitigate urgent quality issues.
• Conducts research into regulatory precedents and legislative history of the Acts enforced by FDA.
• Leads or participates in domestic and/or foreign inspections as necessary

How to Apply

All qualified candidates should submit their resume and transcripts to OPQOQSRecruitment@fda.hhs.gov no later than April 12, 2024. The application period will close either on April 12, 2024, or after the Agency receives 100 resumes (applications).

Once that number has been reached, the vacancy announcement will close.

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: OQS: 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 OPQOQSRecruitment@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.