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
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer to serves as a Subject-Matter-Expert (SME) with responsibilities for protecting the public health of U.S. consumers from unapproved and misbranded drug products through the enforcement of compliance laws and regulations.
Science Policy Analyst
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Science Policy Analyst to provide advice and consultation to Office management on program policy matters, including scientific area of expertise.
Lead Physician
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Lead Physician serves as principal advisor to the Division of Clinical Review (DCR) leadership for all classes of drugs, responsible for leading, planning, carrying out drug programs and research project reviews and studies, risk management, and evaluation of complex issues that may impact the safety, efficacy, and/or bioequivalence of a wide variety of generic products.
Director
Office of Information Systems Management The Office of Regulatory Affairs (ORA), Office of Information Systems Management (OISM) is recruiting for a Director to be responsible for assessing, identifying, and ensuring the technical needs for the ORA, the agency and the programs are met.
This position is being announced as an Information Technology (IT) Management Series, 2210/ Computer Science Series, 1550 and Miscellaneous Administration and Program Series, 0301.
- To learn more about this position in the 2210 & 1550 series and to apply, click here.
- To learn more about this position in the 0301 series and to apply, click here.
Operations Research Analyst (Decision Support and Analysis Staff)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for an Operations Research Analyst, Decision Support and Analysis Staff to serve as coordinator and focal point for Center to facilitate the advancement, operationalization, and use of structured benefit-risk assessment into regulatory.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Regulatory Counsel to serve as an expert in biologic and biosimilar-related policy and will lead, monitor, and review the development and implementation of regulatory policies, standards, and procedures related to biosimilar and interchangeable products.
Dental Officer
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Dental Officer to provide 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; monitoring the post market safety and effectiveness of medical drug products marked and used nationwide.
Lead Pharmacologist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is recruiting for a Lead Pharmacologist in the Division of Therapeutic Performance II (DTP II), Office of Research and Standards (ORS) within OGD to lead a team of professionals who focus on immediate release of oral drug products, lead the product-specific guidance development process providing timely product specific guidance and pre-application scientific advice to generic drug developers.
Interdisciplinary Scientist (Pharmacology/Toxicology)
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Safety and Clinical Evaluation (OSCE), Division of Pharmacology and Toxicology Review (DPTR) is recruiting for an Interdisciplinary Scientists (Pharmacology/Toxicology) to review, evaluate, and determine the approvability of regulatory submissions and applications that request FDA consideration for clinical research, testing, and manufacturing of human drugs and other related regulatory submission specialty areas.
Interdisciplinary Scientist (Pharmacokineticist)
The Center for Drug Evaluation and Research (CDER), Office of Bioequivalence, Office of Safety and Clinical Evaluation, and Office of Research and Standards are recruiting for Interdisciplinary Scientists (Pharmacokineticists) to conduct the scientific evaluation of generic drug products and determines the acceptability of scientific and regulatory applications through the assessment and evaluation of submissions.
Division Director (Division of Biomedical Informatics, Research & Biomarker Development)
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Division Director, Division of Biomedical Informatics, Research & Biomarker Development to provide direction, oversight, and leadership to subordinate staff comprised of multidiscipline reviewers. The review teams are multidisciplinary scientific teams that review and provide consults in relation to biomarker development and regulatory science activities that affect the approvability of regulatory submissions and applications.
Director, Europe Office
The Office of the Commissioner, Office of Policy, Legislation and International Affairs, Office of Global Policy and Strategy, Office of Global Operations is recruiting for a Director, Europe Office to serve as an agency technical expert in working with senior, policy-level officials and technical specialist at other U.S. regulatory agencies, such as the U.S. Department of Agriculture, and others; which work in areas that impact FDA.
Director, Office of Global Operations
The Office of the Commissioner, Office of Policy, Legislation and International Affairs, Office of Global Policy and Strategy, Office of Global Operations is recruiting for a Director, Office of Global Operations to utilize expert knowledge of global health policy, diplomatic and foreign affairs, and Department of State for deployed personnel and provide scientific and technical direction to the foreign offices.
Pharmacist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy and Office of Regulatory Operations are recruiting to provide technical direction to various aspects of the assessment of ANDAs and other generic drug submissions by performing regulatory duties that support the public health mission to help ensure high quality, affordable generic drugs are available to the American public. Pharmacists oversees all administration pertaining to Advisory Committee Meetings under the Federal Advisory Committee Act requirements and develops, coordinates, and ensures documents, correspondence, and policies are sufficiently finalized for supervisory review and approval.
Interdisciplinary Scientist
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for an Interdiscplinary Scientist to review and evaluate drug applications and communicate 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.
Regulatory Health Project Manager
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Health Project Manager to provide technical direction to team members within OGD to support the public health mission to help ensure high quality, affordable generic drugs are available to the American public.
Branch Chief (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 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. Provides guidance to sponsors regarding all phases of clinical development.
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 to serve 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 to serve as 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.
Pharmaceutical Scientist (Research Scientist)- Office of Testing Research (OTR)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist (Research Scientist) to serve on multi-disciplinary scientific teams and provides technical guidance in research activities which generally include the characterization of drug products, its formulation and manufacturing process as it relates to drug delivery, in vitro drug release and in vivo drug performance.
Pharmaceutical Scientist- Office of Pharmaceutical Manufacturing Assessment (OPMA)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist to review and evaluate comprehensive information and data on the manufacturing process and controls, microbiology controls and sterility assurance, and the implementation of the manufacturing control strategy at facilities submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate.
Pharmaceutical Scientist- Office of Biotechnology Products (OBP)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist to review and evaluate 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.
Pharmaceutical Scientist- Office of New Drug Products (ONDP)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for a Pharmaceutical Scientist to review and evaluate 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 Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Regulatory Counsel to develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products.
Pharmacist
The Center for Drug Evaluation and Research (CDER), Office of Executive Programs (OEP) is recruiting for a Pharmacist to serve as a Designated Federal Officer (DFO), oversees all administration pertaining to Advisory Committee Meetings under the Federal Advisory Committee Act requirements and develops, coordinates, and ensures documents, correspondence, and policies are sufficiently finalized for supervisory review and approval.
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.