Title 21 Job Opportunities
The 21st Century Cures Act was enacted on December 13, 2016 and Section 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FY23 Food and Drug Omnibus Reform Act expanded this authority further amending Title 21 to include cross-cutting operational positions and individuals that support the development review and regulation of food and cosmetics in addition medical products. (codified into Title 21 of the United States Code (21 US Code 379d-3a).
The positions listed below are being filled under Title 21. The candidate selected for these positions will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here
Title 21 Open Vacancies
Regulatory Counsel
Center for Evaluation and Research (CDER)
Closing Date: May 18, 2023
Lead Clinical Analyst
Center for Evaluation and Research (CDER)
Closing Date: May 10, 2023
Clinical Analyst
Center for Evaluation and Research (CDER)
Closing Date: May 10, 2023
Health Communications Specialist
Center for Drug Evaluation and Research (CDER)
Closing date: May 9, 2023
Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist)
Center for Drug Evaluation and Research (CDER)
Closing date: June 2, 2023
Laboratory Branch Director
Office of Regulatory Affairs (ORA)
Closing date: May 12, 2023
Physician
Office of Therapeutic Products (OTP) Office of Regulatory Affairs (ORA)
Closing date: June 2, 2023
Pharmaceutical Scientist (Telework Eligible)
Center for Drug of Evaluation and Research (CDER)
Closing date: May 12, 2023
Associate Director Policy – Neurological Stakeholder Engagement
Center for Biologics Evaluation and Research (CBER)
Closing Date: May 10, 2023
Lead Physician (Hematology)
Center for Biologics Evaluation and Research (CBER)
Closing Date: May 31, 2023
Physician (Hematology)
Center for Biologics Evaluation and Research (CBER)
Closing Date: May 31, 2023
Senior Physician (Medical Officer)
Critical Foods Center for Food Safety & Nutrition (CFSAN)
Closing Date: May 10, 2023
Deputy Super Office Director (Supervisory Regulatory Counsel)
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 5, 2023
Deputy Division Director, Division of Pharmacology Toxicology (DPT)
Center for Drug Evaluation and Research (CDER)
Closing Date: May 5, 2023
Lead Regulatory Counsel
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 5, 2023
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 12, 2023
Physician (Allergist)
The Center for Biologics Evaluation and Research (CBER)
Closing Date: May 20, 2023
Clinical Analyst
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 3, 2023
Quality Assurance Specialist (Hybrid)
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 1, 2023
Lead Regulatory Counsel
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 5, 2023
Consumer Safety Officer (Telework Eligible)
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 19, 2023
Mathematical Statistician
The Center for Biologics Evaluation and Research (CBER)
Closing Date: April 28, 2023
Social Scientist/Psychometrician
The Center for Devices and Radiological Health (CDRH)
Closing Date: May 17, 2023
Regulatory Health Project Manager
The Center for Biologics Evaluation and Research (CBER)
Closing Date: May 1, 2023
Mathematical Statistician
The Center for Biologics Evaluation and Research (CBER)
Closing Date: April 28, 2023
Project Manager, Policy and Special Projects Staff
The Center for Biologics Evaluation and Research (CBER)
Closing Date: May 1, 2023
Lead Clinical Analyst
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 1, 2023
Pharmacokineticist
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 1, 2023
Social Science Analyst
The Center for Drug Evaluation and Research (CDER)
Closing Date: May 15, 2023
Assistant Director (DHT4A)
The Center for Devices and Radiological Health (CDRH)
Closing Date: May 12, 2023
Laboratory Director
Office of Regulatory Affairs (ORA)
Closing Date: May 11, 2023
Director
China Office Office of the Commissioner
Close Date: May 5, 2023
Branch Chief, Oncology Branch 2 (OB2)
The Center for Biologics Evaluation and Research (CBER)
Closing Date: July 6, 2023
Super Office Director
The Center for Biologics Evaluation and Research (CBER)
Closing Date: 05/31/2023
Consumer Safety Officer (Telework Eligible)
Center for Drug Evaluation and Research (CDER)
Close Date: 05/11/2023
Data Scientist
Center for Drug Evaluation and Research (CDER)
Close Date: 05/01/2023
Division Director, Division of Dermatology and Dentistry
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Division Director, Division of Dermatology and Dentistry.
Physician (Surgeon/Neurologist/Radiologist/Nuclear Medicine)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruting for a Physician (Surgeon/Neurologist/Radiologist/Nuclear Medicine). As a Physician (Surgeon/Neurologist/Radiologist/Nuclear Medicine), the incumbent will be responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs, including decisions related to changes to already marketed products.
Social Scientist
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA) is recruiting for a Social Scientist. As a Social Scientist, the incumbent is responsible for assisting in the evaluation, implementation, and analysis-related consultative services that directly supports CDER programs, e.g., CDER Breakthrough Therapy Program, Externally Led Patient Focused Drug Development Program, Office of New Drug COVID Response, etc. With moderate oversight, provides recommendations on the planning, design, implementation, and analysis of regulatory requirement, public health issue, or maximize the efficiency of a process.
Regulatory Policy Analyst-Guidance (OP)
The Center for Devices and Radiological Health (CDRH), Office of Policy (OP) is recruiting for a Regulatory Policy Analyst-Guidance. the Regulatory Policy Analyst-Guidance will primarily be responsible for: drafting guidance documents and other policy documents, and collaborative policy development within CDRH, specifically for medical devices and radiological health products; leading work groups to accomplish these responsibilities and objectives; coordinating with other FDA Centers and Offices; analyzing public comments on guidance documents and implementing appropriate revisions; and providing regulatory/policy support regarding the policies and procedures relevant to the development and issuance of CDRH guidance documents.
Physician (Dermatologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Physician (Dermatologist).
Physician (Pediatric Cardiologist)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Physician (Pediatric Cardiologist). As a Physician (Pediatric Cardiologist), the incumbent will be responsible for providing regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs, including decisions related to changes to already marketed products.
Pharmacist
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for a Pharmacist. As a Pharmacist, the incumbent serves as an integral part of the drug safety surveillance and review process within OSE.
Physician
The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is recruiting for a Physician. The incumbent serves as a Physician within the Office of Therapeutic Products (OTP). The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP.
Chief Critical Foods Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Closing date: May 10, 2023
Consumer Safety Officer (Investigator)
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO) is recruiting for multiple Consumer Safety Officers (Investigator). The Consumer Safety Officer (CSO) has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OBIMO program such as: clinical investigators, nonclinical laboratory facilities, sponsors, contract research organizations, institutional review boards, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies.