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
Lead Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Lead Consumer Safety Officer to be responsible for leading a team within Compounding Branch 5, Division of Compounding Policy and Outreach (DCPO), Office of Compounding Quality and Compliance (OCQC), Office of Compliance.
To learn more about this position and to apply, click here.
Supervisory General Health Scientist
The Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD) is recruiting for a Supervisory General Health Scientist to manage and lead FDA's efforts to broaden the FDA Opioid priorities in alignment with the Health and Human Services (HHS) Overdose Prevention Strategy and FDA Overdose Prevention Strategy.
Physician
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Physician to serve 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.
Consumer Safety Officer (Band C)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer to review recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug & Cosmetic (FD&C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability.
Consumer Safety Officer (Band D)
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) is recruiting for a Consumer Safety Officer to review recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug and Cosmetic (FD&C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting for a Regulatory Counsel to be 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.
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.
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 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.
Lead Quality Assurance Specialist
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Lead Quality Assurance Specialist to serve as a subject matter expert and conducts quantitative and qualitative analyses to ensure efficient and consistent work processes and products across OGD.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is recruiting for a Deputy Office Director to serve as the primary advisor to the Office Director, providing expert-level administrative, technical, and regulatory support on all matters related to generic drug regulatory authorities.
Associate Director for Science
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) is recruiting for an Associate Director for Science to serve as a technical expert and senior advisor to the Deputy and Office Director for the Office of Policy for Pharmaceutical Quality (OPPQ) on matters related to the advancement of policy related to pharmaceutical quality by providing expert scientific experience and extensive knowledge of Federal statutes and regulations.
Data Curation Lead
The Office of the Commissioner, Office of Digital Transformation, Office of Data, Analytics and Research is recruiting for a Data Curation Lead to advance the agency’s strategic vision for applying data curation, strategy, and services, ensuring data quality, managing data life cycles, developing project plans, and guiding execution teams.
Lead Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) 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.
Deputy Division Director
The Center for Drug Evaluation & Research (CDER), Office of New Drugs (OND) is recruiting for a Deputy Division Director to serve as the principal advisor to the Division Director and assists with providing leadership and technical direction to scientific review staff engaged in review and evaluation of Investigational New Drug Applications (INDs) and NDA application.
NOTE: Open to current employees. Must be currently employed by the Food & Drug Administration, serving on an appointment in the excepted or competitive service.
Program Analyst
The Center for Biologics Evaluation and Research (CBER), Office of Management (OM) is recruiting for a Program Analyst to lead procedural and process changes through developing and applying new strategies to emerging problems and new management initiatives, allocating dollars and staff resources to CBER’s program office.
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.
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.