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  1. Jobs and Training at FDA

Title 21: 21st Century Cures Act Positions

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 positions listed below are being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. 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

Public Affairs Specialist (Press Officer) (Band B & C) 

The Office of the Commissioner (OC), Office of External Affairs (OEA), Office of Media Affairs (OMA) is recruiting for a Public Affairs Specialist (Press Officer) to be responsible for the coordination of media relations activities for assigned “beat” areas.

Public Affairs Specialist (Press Officer) (Band D)

The Office of the Commissioner (OC), Office of External Affairs (OEA), Office of Media Affairs (OMA) is recruiting for a Public Affairs Specialist (Press Officer) to be responsible for the coordination of media relations activities for assigned “beat” areas. 

Project Coordinator 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) is recruiting for a Project Coordinator to support the development and review of regulation of medical products.

Consumer Safety Officer

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) is recruiting for a Consumer Safety Officer to serve as the regulatory manager/coordinator for an assigned group of drug/biologic products or office level programs. 

Interdisciplinary Scientist (IDS) 

The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP), Division of Translational and Precision Medicine (DTPM) is recruiting for an Interdisciplinary Scientist (IDS) to serve as the scientific expertise as a member of multi-disciplinary scientific and medical teams engaged in review, evaluation, and decision-making regarding approvability of submissions and applications requesting FDA regulatory consideration of clinical research. 

Deputy Division Director 

The Center for Biologics Evaluation and Research (CBER), Office of Management (OM), Division of Management Planning and Analysis (DMPA) is recruiting for a Deputy Division Director to serves as the Deputy Division Director of the Division of Management Planning and Analysis (DMPA) under the Office of Management (OM) and manages daily operations of the Division. 

Physician (Hematology) 

The Center For Biologics Evaluation and Research (CBER), Office Of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Physician (Hematology) to serve as a clinical reviewer, with a specialty in Hematology, who is a reviewer and advisor to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products. 

Lead Physician (Hematology) 

The Center For Biologics Evaluation and Research (CBER), Office Of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Lead Physician (Hematology) to serves as a secondary reviewer and is one of the principal advisors to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products. 

Branch Chief 

The Center For Biologics Evaluation and Research (CBER), Office Of Tissues and Advanced Therapies (OTAT), Division Of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) is recruiting for a Branch Chief to guide the clinical review program which include evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. 

Supervisory Senior Scientist 

The Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE) is recruiting for a Supervisory Senior Scientist to serve as an authoritative expert and resource to facilitate the application of quality regulatory science and science policy for the review and regulation of new and generic animal drugs. 

Interdisciplinary Scientist (IDS)

The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Study Integrity and Surveillance (OSIS) is recruiting for an Interdisciplinary Scientist (IDS) to serve and be responsible for evaluating scientific data and analytical and bioanalytical methods contained in the new or generic drug submissions to the Agency. 

Lab Chief 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR) is recruiting for a Lab Chief to serve as a senior advisor to the Deputy Director and plans, manages, organizes, and directs all laboratory functions, surveillance testing, and laboratory-based investigational activities as carried out by a highly trained and skilled staff of scientific professionals. 

Interdisciplinary Scientist

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdisciplinary Scientist to be responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology/toxicology or clinical drug review divisions located within OND.

Pharmacist 

The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is hiring a Pharmacist to review the proposed proprietary names, product designs, labels, labeling and packaging for their potential to contribute to medication errors. 

Lead Regulatory Counsel 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ) is recruiting for a Lead Regulatory Counsel to assume primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy; that their need is justified, and that scientific and regulatory decisions have been appropriately documented. 

Pharmaceutical Scientist 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Lifecycle Drug Products (OLDP) is recruiting for a Pharmaceutical Scientist to responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. 

Regulatory Health Project Manager 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Program & Regulatory Operations (OPRO) is recruiting for a Regulatory Health Project Manager to coordinate/manage the application review process for an assigned group of drug/biological products or office level programs associated with drug quality application review and facility inspections throughout the drug product lifecycle. 

Pharmaceutical Scientist 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Manufacturing Assessment (OPMA) is recruiting for a Pharmaceutical Scientist to be responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. 

Science Policy Analyst 

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Policy for Pharmaceutical Quality (OPPQ) is recruiting for a Science Policy Analyst to provide advice and consultation to Office management on program policy matters, including those in the incumbent’s scientific area of expertise. 

Consumer Safety Officer – International (CSOI) 

The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Pharmaceutical Quality Operations (OPQO), Division of Foreign Pharmaceutical Quality Inspections (DFPQI), Foreign Pharmaceutical Quality Inspection Branch I and II (FPQIBI & FPQIBII) is recruiting for a Consumer Safety Officer – International (CSOI) (Band C) to serve as a foreign and national authority in inspectional and investigative techniques within multiple functional areas, with an intensive awareness of current and emerging technologies. This position is being advertised at two different levels. 

To learn more about this position, click below.

Branch Chiefs- Foreign Pharmaceutical Quality Inspection Branch I and II (2 vacancies) 

The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Pharmaceutical Quality Operations (OPQO), Division of Foreign Pharmaceutical Quality Inspections (DFPQI), Foreign Pharmaceutical Quality Inspection Branch I and II (FPQIBI & FPQIBII) is recruiting for Branch Chiefs to serve as the focus for international medical product (i.e., pharmaceutical) investigational and related operations. 

Associate Director for Public Health Initiatives 

The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Associate Director for Public Health Initiatives to assist the Super Office Director in executing the above responsibilities by serving as the Office’s lead scientific expert on Office activities related to complex, multidisciplinary drug safety matters with a broad public health impact. 

Statistician 

The Office of Regulatory Affairs (ORA) is recruiting for a Statistician to serve as a technical advisor to the Associate Commissioner for Regulatory Affairs (ACRA) and the Deputy ACRA (DACRA), analyzing FDA/ORA-wide cost initiative requirements and functions. 

Physician (Endocrinologist) 

The Center for Drug Evaluation and Research (CDER) , Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN), Division of General Endocrinology (DGE) is recruiting for a Physician (Endocrinologist) who will be responsible for providing regulatory oversight for investigation studies during drug development and making decisions regarding marketing approval for new (innovative or non-generic) drugs.

Scientific Data Analyst 

The Center for Biologics Evaluation and Research (CBER), Office of the Center Director (OD), Science Staff (SS) is recruiting for a Scientific Data Analyst to work as part of a team in managing multiple computer–based systems (i.e., Research Central and REES Environmental Monitoring System) that are used for monitoring and tracking regulatory science and research activities, such as research programs, publications, and related research program support budgets. 

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