Regulatory Counsel - FDA (Remote)

Introduction

The Food and Drug Administration (FDA or Agency) 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 are safe, and effective.

FDA's Center for Food Safety and Applied Nutrition (CFSAN or Center) is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

Specifics

Internal Number: 0301

This position is being filled under a streamlined 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

Bargaining Unit: 3591, National Treasury Employee Union

United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Qualifications
To be placed into a Cures position, candidates must meet the following criteria:Scientific, Technical, and Professional Fields
Qualified and Outstanding Candidates Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Desired Professional Experience

A juris doctorate degree from an accredited institution of higher learning.
Expertise in the development, monitoring, coordination, and implementation of FDA policies and regulatory issues related to foods, dietary supplements, and cosmetics; responds to inquiries and correspondence directed to the Center Director, Commissioner, Principal Deputy Commissioner, and other senior FDA staff.
Experience using laws to develop and review regulatory or policy documents concerning complex and high priority matters affecting the regulation of foods, including dietary supplements.
Expertise in applying regulatory and policy issues and expert regulatory drafting and review experience to lead major initiatives, such as the development of proposed and final rules, draft and final guidance documents, and other policy documents related to FDA’s regulation of foods, dietary supplements, and cosmetics.
Experience in reviewing documents drafted by other staff, to include drafting and critically reviewing team responses to complicated topics that raise various regulatory and policy issues and affect the regulated industry.
Experience analyzing, interpreting, and implementing complex legislative matters relating to authorizing statutes.

How to Apply
Submit resume or curriculum vitae with cover letter by the closing date as identified above to CFSAN-Cures@fda.hhs.gov. Candidate resumes may be shared with hiring officials within CFSAN with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CFSAN-CURES@fda.hhs.gov. Please reference Job Reference ID: “ORP Regulatory Counsel” when applying.

Announcement Contact
For questions regarding this Cures position, please contact CFSAN-CURES@fda.hhs.gov. Please reference Job Reference ID: “ORP Regulatory Counsel”

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

FDA is an equal opportunity employer.