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 or Agency) is the regulatory, scientific, public health and consumer protection agency that regulates human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices.

The Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

Duties/Responsibilities

The incumbent serves as a Consumer Safety Officer in the Biological Drug and Device Compliance Branch (BDDCB) within the Division of Case Management (DCM) under the Office of Compliance and Biologics Quality (OCBQ) within CBER. The Consumer Safety Officer serves as a specialist and technical expert in compliance and enforcement with responsibility for the review and analysis of a variety of more complicated cases. The incumbent is responsible for managing a category or group of products that are distinctly more difficult to deal with because of the science and technology behind the regulated products. The Consumer Safety Officer reviews inspection reports submitted by field investigators to determine compliance with applicable laws and regulations.

Specifically, the Consumer Safety Officer will:

• Manage complex legal and regulatory issues based on advanced scientific education and/or long, practical experience in Agency regulatory and compliance processes.
• Perform the full range of compliance and enforcement actions; advisory, administrative, and judicial, including casework and related functional responsibilities in the area of biological drugs and devices.
• Coordinate and evaluate compliance review processes within CBER and across the Agency, draft or edit guidance documents involving Branch matters, mentor, and maintain standard operating policies and procedures regarding compliance and enforcement activities.
• Analyze and determine the adequacy of proposed compliance and enforcement actions by an FDA Center/Office regarding the compliance and enforcement of regulated products with the Federal Food, Drug, and Cosmetic Act.
• Determine if additional data or other information is necessary within the context of applicable laws, policies, regulations, and guidelines.
• Incumbent reviews inspection reports and evaluates the compliance status of licensed biological product manufacturers and is routinely assigned those manufacturers and facilities that involve unusual and/or intricate manufacturing processes and quality controls, and/or a wide variety of biological products.
• Incumbent evaluates Biological Product Deviation Reports from the manufacturers of biological drugs and devices regulated by CBER.
• Incumbent reviews proposed regulatory actions, providing recommendations and guidance to field compliance organizations, and the regulated industry, and representing the Center at local, State, and national meetings on matters concerning regulated products.
• Participate in internal and external meetings to formulate, develop, or explain policy for regulating biological drugs and CBER-regulated devices, advanced or specialized program concepts, accepted or recognized standards, or expertise in scientific or regulatory programs.
• Develop and recommend new and revised guidelines for regulated products and proposing areas of study for new or revised regulatory policy and guidelines.
• Monitor, evaluate, and make necessary recommendations for improvement based on routine surveillance activities, enforcement and compliance actions taken by BDDCB staff.
• Advise the Office Director, Division Director, and Branch Chief, regarding policy matters involving technical aspects of regulation of biological drugs and devices regulated by CBER.
• Lead, as appropriate, requests for advisory opinions for regulated industry, Congress, department officials etc. for the Branch.
• Mentor and develop training for other staff members in evaluating compliance issues for biological products.
• Perform other duties as assigned.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest PMAP (if applicable), copy of your unofficial transcripts, and letter of interest with “CURES CBER/OCBQ/DCM/BDDCB/Consumer Safety Officer” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 7/5/2024.

Announcement Contact

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

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

FDA is an equal opportunity employer.