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
Branch Chief (Supervisory 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 Branch Chief (Supervisory Physician Hematology) 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.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drugs and Labeling Compliance (OUDLC) is recruiting for 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.
Interdisciplinary Scientist
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 Scientist to serve on a multidisciplinary pharmacology/toxicology team that reviews, evaluates, and determines 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.
Division Director (Supervisory Interdisciplinary Scientist)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR), Division of Product Quality Research (DPQR) is recruiting for a Division Director (Supervisory Interdisciplinary Scientist) to plan, manage, organize, and direct all laboratory functions and activities of the Division as carried out by highly trained and skilled staff of scientific professions.
Lab Chief (Supervisory Chemist)
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR), Division of Pharmaceutical Analysis (DPA) is recruiting for a Lab Chief (Supervisory Chemist) to plan, manage, organize, and direct all laboratory functions and activities carried out by a highly trained and skilled staff of scientific professionals who implement technologies, methods, and procedures for rapid evaluation of drug ingredient and product quality, conduct research on new rapid screening technologies to improve quality surveillance of pharmaceutical products, and provide analytical support to the FDA to address public health emergencies.
Lead Physician
The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Non-Prescription Drugs (ONPD), Division of Non-Prescription Drugs II (DNPDII) are recruiting for a Lead Physician to be responsible for assisting the supervisor with administrative direction and oversight in their assigned clinical division.
Lead Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC), Division of Compounding 1 (DCI) & Division of Compounding 2 (DCII) is recruiting for a Lead Consumer Safety Officer to be responsible for leading a team within a branch of a Division within Office of Compounding Quality and Compliance (OCQC), Division of Compounding I or II.
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.
Staff Director, Lean Management Staff (LMS)
The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP), Office of Program and Strategic Analysis (OPSA), Lean Management Staff (LMS) is recruiting for a Staff Director to develops, plans, and coordinates the work of LMS and provides authoritative guidance to staff on the application of methods, techniques, and procedures for the conduct of studies, process improvement initiatives, and organizational change management efforts to support improvement to regulatory review processes for medical products.
Deputy Office Director
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Bioequivalence (OB) is recruiting for a Deputy Office Director to serve as the primary advisor to the Office Director and provide assistance to the Office Director in the management and direction of the development and implementation of the Agency’s bioequivalence and bioavailability reviews associated with the generic drug program.
Pharmaceutical Scientist
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) 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),
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) to 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, including decisions related to changes to already marketed products.
Division Director
The Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting for a Division Director to review, evaluate and recommend appropriate action on investigational new drug applications (INDs), Biologics License Applications (BLAs), new drug applications (NDAs), and 510 (k) and premarket applications (PMAs).