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 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 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 Regulatory Health Project Manager within the Office of Review Management and Regulatory Review (ORMRR) and under the Office of Therapeutic Products (OTP). This position reports to the applicable Division Director or Branch Chief within ORMRR. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, hematologic and gene therapies and other products regulated by OTP. As the Regulatory Health Project Manager, the incumbent collaborates with similar or higher graded staff to plan, facilitate, implement, and coordinate ORMRR’s regulatory project activities.

Specifically, the Regulatory Health Project Manager will:

• Perform regulatory review activities as a team member, to include facilitating meetings, preparing issue-based agendas, and drafting, finalizing, and providing meeting summaries, in addition to issuing communications (e.g., memos, emails and letters).
• Serve as a liaison between industry and the FDA.
• Provide regulatory guidance to industry and internal review teams.
• Co-lead multidisciplinary teams in the review of submissions for OTP regulated products.
• Provide analysis and evaluation on the implementation of projects.
• Attend and document project meetings and related activities and communications among team members.
• Identify problems, inform Senior Team Staff of the problems, or work on problem resolution efforts.
• Manage product review processes for routine classes of biologics.
• Work to resolve scientific and regulatory conflicts or problems to avoid delays in achieving goals.
• Partner with other members of the review team to develop project plans, including establishing time frames, milestones, and endpoints.
• Monitor the progress and report the status of all activities within the assigned projects through interaction

with project participants and team members.

• Identify project activities or situations that may adversely impact project plan and advise team members of potential impact and recommend solutions to problem areas.
• Serve as the primary point of contact (POC) for the up-to-date status of project progress and representing the team activities to management.
• Analyze review status with respect to variance from project plans and determines impact on established project goals.
• Identify discrepancies in resource needs, team availability and scheduling.

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), unofficial transcripts and letter of interest with “Title 21 CBER/ORMRR Regulatory Health Project Manager” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through July 11, 2024.

Announcement Contact

For questions regarding this Title 21 (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.