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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

Laboratory Director, Forensic Chemistry Center (FCC) 

The Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Medical Products and Specialty Laboratory Operations (OMPSLO), Forensic Chemistry Center (FCC) is recruiting for a Laboratory Director. The Director is responsible for providing leadership, guidance, and technical direction necessary for full and effective program accomplishments and the effective utilization of available resources. 

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). The Physician will 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. 

Deputy Division Director – OCE/DC 

The Center for Devices and Radiological Health (CDRH), Office of Communication and Education (OCE) is reruiting for a Deputy Division Director. Located in the Division of Communication, the Deputy Division Director partners with the Division Director in developing and implementing the Center’s external and internal communication strategy. 

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 Cheif. The Branch Chief guides 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. 

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). The incumbent will serve as a Lead Physician, with a specialty in Hematology, who 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. 

Epidemiologist

The Center for Drug Evaluation and Research (CDER), Divisions of Epidemiology (DEPI I and II) is recruiting for an Epidemiologist who will be responsible for managing pre- and post-approval drug safety and efficacy review, review of epidemiologic submissions from regulated industry, overseeing a portfolio of drug products for which they are responsible for managing post-approval safety and safety signal evaluation.

CVM, Director of the Office of Minor Use and Minor Species (OMUMS) 

The Center for Veterinary Medicine (CVM) is looking to fill a critical leadership position - the Director, Office of Minor Use and Minor Species. The Supervisory Veterinary Medical Officer, Office Director ensures the appropriate evaluation of requests for designation of new animal drugs intended for minor use or minor species in accordance with Section 573 of the Federal Food, Drug, and Cosmetic Act (FFDCA) including initial requests, modification, termination, and annual reports. 

Division Director 

The Center for Devices and Radiological Health (CDRH) is recruiting a Division Director to serve in the Office of Clinical Evidence and Analysis (OCEA or Office). This Office, within the Office of Product Evaluation and Quality (OPEQ), provides policy and programmatic support for clinical trials, the protection of human subjects, biostatistics, real-world evidence, epidemiological analysis and outreach, and collaborates with hospitals, health systems, industry, and other external stakeholders. 

Deputy Director, DMEPA I 

The Center for Drug Evaluation and Research (CDER), Office of Medication Error Prevention and Risk Management (OMEPRM), Divisions of Medication Error Prevention and Analysis I (DMEPA I) is recruitnig for a Deputy Director. As Deputy Division Director, the incumbent shares responsibility with the Director in planning, managing, organizing, and directing all operations, functions, and activities of the Division as carried out by Associate Directors, team leaders and staff with professional, medical, and scientific skillsets such as, physicians, pharmacists, nurses, engineers, and social scientists, serving in the roles of safety evaluators and human factors (HF) specialists to meet the goals and mission of the organization. 

Regulatory Counsel 

The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting for a Regulatory Counsel. As a Regulatory Counsel in the Divisions of Regulatory Policy (DRP) I-IV in the Office of Regulatory Policy (ORP), the incumbent is responsible for writing regulations, preparing responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration; drafting and commenting on legislation; and providing advice on the interpretations of the laws, regulations, and policies applicable to the FDA. 

Interdisciplinary Scientist (Pharmacokineticist) 

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for Interdisciplinary Scientists in the following offices: Office of Bioequivalence, Office of Safety and Clinical Evaluation, and Office of Research and Standards to conduct the scientific evaluation of generic drug products and determine the acceptability of scientific and regulatory applications through the assessment and evaluation of submissions. 

Super Office Director (Office of Therapeutic Products)

The Center for Biologics Evaluation and Research, Office of Therapeutic Products (OTP) is recruiting for a Super Office Director to provide executive leadership to six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy.

Director of Investigations Branch

The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Biological Products Operations (OBPO), Division of Biological Products Operations I (DBPOI) is recruiting for a Director of Investigations Branch. The Director will oversee Biological Product investigators based on program priorities. 

Super Office Director

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting a Super Office Director. As the Director of the Office of Generic Drugs (OGD), the incumbent is responsible for directing OGD activities which include developing and implementing standards for the safety, effectiveness, and quality of generic drugs, reviewing, and evaluating Abbreviated New Drug Applications (ANDAs) and their amendments or supplements to determine approvability, establishing bioequivalence specifications for drug products, including overseeing a regulatory science program to inform these activities, and developing guidelines for bioequivalence reviews, industry protocols, and studies. 

Senior Clinical Advisor for Mental Health 

The Office of the Commissioner is recruiting for a Senior Clinical Advisor for Mental Health to provide advice to the Commissioner and perform substantive work that cuts across major Agency-wide programs and activities. 

Senior Clinical Advisor for Chronic Disease

The Office of the Commissioner is recruiting for a Senior Clinical Advisor for Chronic Disease to provide advice to the Commissioner and perform substantive work that cuts across major Agency-wide programs and activities. 

Associate Director for Regulatory Project Management 

The Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance (OBPV), Division of Pharmacovigilance (DPV) is recruiting for an Associate Director for Regulatory Project Management to serve as a focal point for information, operations and management review policy and implementation issues that require management and coordination; and assigns incoming documents and provides signoff on regulatory communications. 

Regulatory Health Project Manager

The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) 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. 

Interdisciplinary Scientist

The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for an Interdisciplinary Scientist to serve as a technical reviewer evaluating and conducting inspections of nonclinical laboratory studies (GLP studies) and the clinical and bioanalytical portions of bioavailability and bioequivalence studies supporting new and generic drug submissions to the FDA to help ensure the health and welfare of research participants, the reliability of study data, and compliance with United States laws and regulations, in support of protecting the public health. 

OCP Director

The Office of Clinical Policy and Programs (OCPP), Office of Combination Products (OCP) is recruiting for an Office Director to serve as an advisor to the OCPP Director, FDA's Chief Medical Officer, and other key Agency officials on legislation, regulations, programs and policies concerning the regulation of combination products. 

Senior Advisor (Medical Countermeasures Coordinator) 

The Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations is recruiting for a Senior Advisor (Medical Countermeasures Coordinator) in multiple district offices to serve as the ORA authority with medical countermeasures (MCM) and advanced medical products manufacturing. Recommends operational policy relating to domestic and international program area through the preparation of opinion papers and providing advice and counsel to ORA management corresponding to the specialty area. 

Development Coordinator

The Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations is recruiting for a Development Coordinator in multiple district offices to provide advice and counsel to the Association Director for Advanced Medical Products Manufacturing (AMPM) and other Agency leaders on advanced manufacturing training needs and activities to ensure regulatory training keeps pace with industry advancements. 

Regulatory Program Manager

The Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations is recruiting for a Regulatory Program Manager in multiple district offices to develop, implement, and evaluate programs and projects; design, plan, develop and enhance OMPTO projects and programs of high visibility, conducts special studies, meets, and consults with heads of various agency functions and provides consultation and expert advice in the coordination of projects between several different organizations. 

Program Expert

The Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations is recruiting for a Program Expert in multiple district offices to serve as a subject matter expert in inspectional and investigational techniques and provide authoritative advice to ORA senior leadership in advanced manufacturing for medical products. 

Data Scientist 

The Center for Drug Evaluation and Research, Office of Strategic Programs (OSP) is recruiting for a Data Scientist to serve as a consultative service to the Center that help inform decisions impacting Center regulatory policies and programs. 

International Policy and Program Analyst

The Office of Global Policy and Strategy is recruiting for an International Policy and Program Analyst to advances OGPS implementation of strategic plans and priorities by developing documents, briefing papers, presentations, or other materials that can be used to enhance global regulatory oversight of FDA regulated commodities. 

Deputy Director (Beijing, China and New Delhi, India) 

The Office of Global Policy and Strategy is recruiting for a Deputy Director in Beijing China and New Delhi, India to supervise a group of employees and provides administrative and technical supervision as well as human resources management functions and oversee the effectiveness of administration of FDA agreements with foreign representatives. 

Associate Director for Professional Development 

The Center for Devices and Radiological Health is recruiting for an Associate Director for Professional Development (ADPD) who will be responsible for overseeing programs that foster the professional development of the multidisciplinary workforce within the Office. The ADPD advises and directs the professional and overall development of all employees in the Office. This includes coaching, mentoring, and assessing professional development needs and analyzing program effectiveness, providing expert advice to higher level management regarding the Office’s professional development, and recommending improvements to support employee development across the Office. 

Supervisory Staffing and Recruitment Team Lead

The Center for Veterinary Medicine is recruiting for a Supervisory Staffing & Recruitment Team Lead to perform day-to-day hiring /recruitment activities to ensure that CVM can meet annual hiring goals. Consult with and provide guidance to hiring managers on hiring authorities and process, classification, outreach, and other hiring-related issues, utilizing expert knowledge of policy, guidance, and best practices. 

Regulatory Counsel 

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Counsel. As a Regulatory Counsel, the incumbent develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products. Drafts or critically reviews documents that state or interpret Center or FDA policy for the regulated industry and other effected groups, embodying policy and program proposals and decisions on these products. 

General Health Scientist 

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for General Health Scientist. As a General Health Scientist, the incumbent is responsible for the evaluation of the safety, efficacy, and/or substitutability of generic drugs consumed by the American people. Researches appropriate precedents, databases, and reference material in depth to gather, review, and evaluate existing regulations and guidance and new information about specific drug products or drug classes.

Physician 

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Physician. As a Physician, the incumbent serves as a primary reviewer responsible for the scientific evaluation of clinical studies supporting development and approval of generic drugs. Assesses substitutability for proposed generic drug-device combination products, including assessment of comparative analysis.

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. The Branch Chief guides 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. 

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). The incumbent will serve as a Lead Physician, with a specialty in Hematology, who 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. 

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). The Physician will 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. 

Deputy Division Director (Pharmacokineticist) 

The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Deputy Division Director (Pharmacokineticist). As the Deputy Division Director, the incumbent serves as the alter ego to the Division Director in the oversight, leadership, and management of the division. This includes aiding in the management and direction of the regulatory science and technical support activities on all matters related to chemistry, pharmacology, pharmacokinetic, modeling, simulation, and analytical tools used in the assessment of generic drug products. 

Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist) 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) ia recruiting for an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist). As an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist), the incumbent is responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team. 

Deputy Office Director 

The Office of Clinical Policy and Programs (OCPP), Office of Orphan Products Development (OOPD) is recruiting for a Deputy Office Director. The incumbent serves as Deputy Director of OOPD, representing senior management in scientific and regulatory matters and provides direction, coordination, and leadership in areas related to orphan drugs and rare diseases. 

Director, Center for Veterinary Medicine (CVM) 

The Center for Veterinary Medicine is recruiting for a Director to provide overall leadership and management for the Center, coordinates and works to integrate CVM programs with those of the other FDA Centers; serves as a liaison between FDA and other government agencies, academic institutions and private organizations; and is responsible for the direction, performance and quality of CVM's programs and activities. 

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