How to Apply
FDA Pharmacy Student Experiential Program (PSEP)
Eligibility Requirements
To be eligible for participation in the FDA Pharmacy Student Experiential Program, students must meet the following criteria:
- U.S. citizenship.
- Enrollment in an ACPE-accredited pharmacy school program.
- Eligibility to begin Advanced Pharmacy Practice Experience (APPE) rotations, adhering to any requirements specified by their pharmacy school.
Due to HSPD-12 requirements for issuance of a PIV identification card, students selected for placement with certain PSEP rotation sites must be able to successfully pass a Tier 1 background investigation. These students should expect to have fingerprints taken and submitted, as well as answer questions about where they have lived, worked, gone to school, and any military history or police records. PSEP students must be U.S. citizens and have maintained residence in the United States for at least 3 of the past 5 years.
Students are strictly prohibited from releasing, publishing, or disclosing non-public information, specifically any confidential commercial or trade secret information obtained while serving as an FDA student.
For a comprehensive and detailed list of all requirements, please refer to the Manual of Policies and Procedures (MAPP) 4410.1 – FDA Pharmacy Student Experiential Program.
Application Procedures
FDA PSEP accepts applications from interested students in the fall preceding their final year of pharmacy school (i.e., typically at the start of the third professional year). The application period is now open and will close on December 13, 2024. Details will be provided to pharmacy school experiential coordinators.
With support from their pharmacy school’s experiential coordinator, students should utilize the FDA PSEP online application system to apply. A complete application includes the following:
- Resume or curriculum vitae.
- A one-page essay outlining the student’s career goals and how a rotation at FDA will contribute to achieving those goals.
- Optional: Up to three preferred rotation sites.
- Optional: Up to three preferred rotation date blocks.
- Optional: Preferred rotation setting (e.g., on-site, remote, or hybrid).
An automated acknowledgment email will be sent to both the applicant and their experiential coordinator after receipt and review of the submission for completeness.
Students who are selected for placement will receive direct notification from a preceptor at FDA in January or February 2025. Students who are not selected for placement should expect to receive notification from their experiential coordinator in March confirming they were not placed in a rotation block with FDA.
Rotation Sites
Please note: this list is subject to modification at any time based upon preceptor availability. A student may also be offered a rotation with a preceptor whose site is not listed here.
Use filter and search box to find rotation sites
Advanced search (combine rotation method and search terms).
| Center, Super Office | Site Name | Method | Location | Areas of Rotation Focus | Badging required (31 days minimum) |
|---|---|---|---|---|---|
| Center for Biologics Evaluation and Research (CBER), Office of Compliance & Biologics Quality (OCBQ) | Bioresearch Monitoring Branch | Hybrid | Silver Spring, MD | Approval Process, Biologics License Application (BLA), Clinical Research, Investigational New Drug (IND) Application, Inspections, Project Management, Regulatory Affairs, Regulatory Operations, Review Process | Yes |
| Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research & Review (OVRR) | Division of Review Management & Regulatory Review | Hybrid, On-site | Silver Spring, MD | Vaccine development process from preclinical research to market approval; different regulatory pathways for accelerating vaccine approval; post-marketing surveillance for vaccines; Project management | Yes |
| Center for Devices and Radiological Health (CDRH), Office of Product Evaluation & Quality (OPEQ) | Immediate Office, Postmarket Programs | Remote | Remote | Medical Devices, Postmarketing Programs, Regulatory Policy, Safety Reporting, Safety Signal Management | TBD |
| Center for Devices and Radiological Health (CDRH), Office of Product Evaluation & Quality (OPEQ) | Office of Health Technology 5 (Office of Neurological & Physical Medicine Devices) | Hybrid, Remote | Silver Spring, MD | Medical Devices, Neurological and Physical Medicine | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM) | Division of Drug Information | On-site | Silver Spring, MD | Drug Information, Inquiry Responses, MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Small Business and Industry Assistance (SBIA), Social Media, Stakeholder Engagement | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Compounding Quality & Compliance | Hybrid, Remote | Silver Spring, MD | Compliance, Compounding, Quality Assurance, Regulatory Policy, Safety Reporting | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Compounding Quality & Compliance, Division of Compounding Policy & Outreach | Hybrid, Remote | Silver Spring, MD | Compounding, Policy Development, Policy Implementation, Regulatory Enforcement, Stakeholder Engagement | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Manufacturing Quality | Hybrid, On-Site, Remote | Silver Spring, MD | Compliance, Current Good Manufacturing Practice (CGMP), Inspections, Manufacturing | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Program & Regulatory Operations | Remote | Remote | Approval Process, Bulks List, Compounding, Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Scientific Investigations | Remote | Remote | Bioavailability/Bioequivalence (BA/BE), ClinicalTrials.gov, Good Clinical Practice (GCP), Inspection Evaluation/Action | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Scientific Investigations, Division of Enforcement & Postmarket Safety | Hybrid | Silver Spring, MD | Bioavailability/Bioequivalence (BA/BE), ClinicalTrials.gov, Good Clinical Practice (GCP), Inspections, Postmarketing Programs, Regulatory Enforcement | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Unapproved Drugs & Labeling Compliance | Remote | Remote | Compliance, Drug Product Listing, Establishment Registration, Fraud and Dangerous Drugs, Human Drug Products, Labeling, Review Process | No |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) | Office of Unapproved Drugs & Labeling Compliance, Division of Labeling, Registration & Unapproved Drugs, Drug Registration & Labeling Branch | Remote | Remote | Compliance, Data Quality, Data Science, Database Management, Drug Product Listing, Electronic Submissions, Establishment Registration, Inquiry Responses, National Drug Code (NDC), Regulatory Enforcement, Stakeholder Engagement | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Bioequivalence, Division of Bioequivalence I | Hybrid, On-Site | Silver Spring, MD | Bioavailability/Bioequivalence (BA/BE) Assessment, Generic Drug Products, Generic Drug User Fee Amendments (GDUFA), Human Drug Products, Policy Evaluation, Policy Implementation, Postmarketing Programs | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Bioequivalence, Division of Bioequivalence II | Remote | Remote | Generic Drug Products, Pediatrics, Product Development, Rationale for Partial Area Under Curve (pAUC) Recommendation | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Bioequivalence, Division of Bioequivalence III | Hybrid | Silver Spring, MD | Product Development, Regulatory Research, Generic Drug Products | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Bioequivalence, Division of Bioequivalence Process Management | Remote | Remote | Abbreviated New Drug Application (ANDA), Controlled Correspondence, Formal Meetings, Generic Drug Products, Pre-Abbreviated New Drug Application (Pre-ANDA), Product Development, Project Management, Quality Assurance, Suitability Petitions | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Generic Drug Policy | On-site | Silver Spring, MD | Approval Process, Exclusivities, Generic Competition, Generic Drug Products, Policy Development, Policy Implementation | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Generic Drug Policy, Division of Orange Book Publication & Regulatory Assessment | Remote | Remote | Exclusivities, Generic Drug Products, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patents, Policy Development, Project Management | No |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Regulatory Operations, Division of Filing Review | Hybrid | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Controlled Correspondence, Formal Meetings, Generic Drug Products, Pre-Abbreviated New Drug Application (Pre-ANDA), Product Development, Project Management, Quality Assurance, Regulatory Operations, Review Process, Suitability Petitions | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Regulatory Operations, Division of Labeling Review | Hybrid, Remote | Silver Spring, MD | Generic Drug Product development and regulatory processes, quality assurance, project management, ANDA filing review, controlled correspondence, pre-ANDA meetings, suitability petitions, Regulatory Operations | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Regulatory Operations, Division of Project Management | Hybrid, Remote | Silver Spring, MD | Approval Process, Generic Drug User Fee Amendments (GDUFA), Project Management | No |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Research & Standards | Hybrid, Remote | Silver Spring, MD | Clinical Studies, Controlled Correspondence, Formal Meetings, Generic Drug User Fee Amendments (GDUFA), Guidance Document Development, Human Subject Safety, Pre-Abbreviated New Drug Application (Pre-ANDA), Program Evaluation, Real World Evidence (RWE), Regulatory Science, Research | Both |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Safety & Clinical Evaluation, Division of Clinical Review | Hybrid | Silver Spring, MD | Bioavailability/Bioequivalence (BA/BE) Assessment, Clinical Perspective, Drug-Device Combination Products, Generic Drug Products, Therapeutic Equivalence | No |
| Center for Drug Evaluation and Research (CDER), Office of Management (OM) | Division of User Fee Management | Remote | Remote | Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Act (BsUFA), Combination Product User Fee Act (CQA), Over-The-Counter Monograph Drug User Fee Act (OMUFA), management of user fee programs, reauthorization negotiations, determine annual user fees | Both |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Medical Policy Initiatives, Division of Clinical Trial Quality | Hybrid, On-Site, Remote | Silver Spring, MD | Clinical Trials, Policy Development, Quality Assurance | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Medical Policy Initiatives, Division of Medical Policy Programs | Hybrid, On-Site, Remote | Silver Spring, MD | Prescription Drug Labeling Policy Development, Patient Information, Project Management | Both |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Medical Policy Initiatives, Immediate Office | Hybrid, On-Site, Remote | Silver Spring, MD | Artificial Intelligence (AI), International Collaboration and Harmonization, Policy Development, Product Development | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Prescription Drug Promotion | Hybrid, Remote | Silver Spring, MD | Advertising and Promotion, Compliance, Guidance Document Development, Labeling, Policy Development | Both |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Prescription Drug Promotion, Division of Advertising Promotion Review II | Remote | Remote | Advertising and Promotion, Compliance, Guidance Document Development, Labeling, Policy Development | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Immediate Office, Safety Policy Research and Initiatives Team | Hybrid | Silver Spring, MD | Policy Development, Postmarketing Commitments (PMCs), Postmarketing Programs, Postmarketing Requirements (PMRs), Research, Risk Evaluation and Mitigation Strategies (REMS), Safety-Related Initiatives, Sentinel Linkage Coordinator (SLC) | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Cardiology, Hematology, Endocrinology & Nephrology, Division of Cardiology & Nephrology | Hybrid, Remote | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Cardiac Safety Studies, Clinical Trials, Investigational New Drug (IND) Application, Labeling, New Drug Application (NDA), Review Process, Safety-Related Initiatives | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Cardiology, Hematology, Endocrinology & Nephrology, Division of Diabetes, Lipid Disorders & Obesity | Hybrid | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Clinical Trials, Investigational New Drug (IND) Application, Labeling, New Drug Application (NDA), Review Process, Safety-Related Initiatives | Both |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Infectious Diseases, Division of Pharmacology/Toxicology for Infectious Diseases | On-site | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Clinical Trials, Infectious Diseases, Investigational New Drug (IND) Application, Labeling, New Drug Application (NDA), Review Process, Safety-Related Initiatives | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of New Drug Policy | Hybrid, On-Site, Remote | Silver Spring, MD | Human Drug Products, Policy Development, Regulatory Policy, Strategic Initiatives | Both |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Nonprescription Drugs | Hybrid, On-Site, Remote | Silver Spring, MD | Nonprescription Drug Products, Over-The-Counter Monograph Drug User Fee Act (OMUFA), Policy Development, Policy Implementation, Policy Reform, Strategic Initiatives | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Nonprescription Drugs, Division of Nonprescription Drugs II | Hybrid, On-Site, Remote | Silver Spring, MD | Nonprescription Drug Products, Project Management, Safety-Related Initiatives | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Immunology & Inflammation, Pulmonology, Allergy & Critical Care Group | Hybrid | Silver Spring, MD | Approval Process, Investigational New Drug (IND) Application, New Drug Application (NDA), Project Management, Pulmonology, Allergy, and Critical Care, Regulatory Affairs, Regulatory Operations, Review Process | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Immunology & Inflammation, Rheumatology & Transplant Medicine Group | Hybrid, On-Site, Remote | Silver Spring, MD | Approval Process, Immunology and Inflammation, Investigational New Drug (IND) Application, New Drug Application (NDA), Project Management, Regulatory Affairs, Regulatory Operations, Review Process | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Regulatory Operations for Infectious Diseases, Anti-Infectives | Both | |||
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Regulatory Operations for Neuroscience, Anesthesiology, Addiction Medicine & Pain Medicine Group | Hybrid, On-Site, Remote | Silver Spring, MD | Anesthesiology, Addiction Medicine, and Pain Medicine, Approval Process, Investigational New Drug (IND) Application, New Drug Application (NDA), Project Management, Regulatory Affairs, Regulatory Operations, Review Process | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Regulatory Operations for Neuroscience, Psychiatry Group | Hybrid, Remote | Silver Spring, MD | Approval Process, Investigational New Drug (IND) Application, New Drug Application (NDA), Psychiatry, Project Management, Regulatory Affairs, Regulatory Operations, Review Process | Yes |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Regulatory Operations for Nonprescription Drugs | Remote | Remote | Nonprescription Drug Products, New Drug Application (NDA), Over-The-Counter Monograph Drug User Fee Act (OMUFA), Regulatory Affairs | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Regulatory Operations, Division of Regulatory Operations for Specialty Medicine | Hybrid, Remote | Silver Spring, MD | Ophthalmology, Pre-Investigational New Drug Application (Pre-IND), Investigational New Drug (IND) Application, New Drug Application (NDA), Biologics License Application (BLA), Review Process, Labeling, Project Management, drug development, regulatory requirements | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Specialty Medicine, Pharmacy Compounding Review Team | Hybrid, Remote | Remote | Compounding, Approval Process, Bulks List, Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), safety, efficacy, clinical need, uses or indications | No |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Therapeutic Biologics & Biosimilars | Remote | Silver Spring, MD | Biological Products, Biosimilar Products, Exclusivities, Interchangeable Biological Products, Patents, Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, Regulatory Policy | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of Biotechnology Products | Remote | Remote | Biologics Price Competition and Innovation Act of 2009 (BPCI Act), Insulin Products, Monoclonal Antibodies, Postmarketing Programs, Regulatory Policy, Therapeutic Proteins | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of Biotechnology Products, Division of Biotechnology Review & Research II | Remote | Remote | Biologics Price Competition and Innovation Act of 2009 (BPCI Act), Insulin Products, Monoclonal Antibodies, Postmarketing Programs, Regulatory Policy, Therapeutic Proteins | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of Lifecycle Drug Products | Hybrid, Remote | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Compliance, Current Good Manufacturing Practices (CGMP), Generic Drug Products, Human Drug Products, Inspections, Pre- and Post-Approval Application Supplement Submissions, Quality Assurance, Regulatory Policy | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of New Drug Products | Hybrid | Silver Spring, MD | Biopharmaceutics, Chemistry Manufacturing and Controls (CMC), Investigational New Drug (IND) Application, Pre- and Post-Approval Application Supplement Submissions, Quality Assurance, Regulatory Policy | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of Pharmaceutical Manufacturing Assessment | Hybrid, On-Site, Remote | Silver Spring, MD | Biotechnology, Manufacturing, Microbiology, Monoclonal Antibodies, Review Process, Therapeutic Proteins | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) | Office of Program & Regulatory Operations | Remote | Remote | Abbreviated New Drug Application (ANDA), Approval Process, Project Management, Regulatory Affairs, Review Process | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) | Division of Information Disclosure Policy | Hybrid | Silver Spring, MD | Information Disclosure, Freedom of Information Act (FOIA), Inquiry Responses, Stakeholder Engagement | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) | Division of Regulatory Policy IV | Hybrid | Silver Spring, MD | Citizen Petitions, Freedom of Information Act (FOIA), Information Disclosure, Policy Development, Postmarketing Programs, Risk Evaluation and Mitigation Strategies (REMS), Safety-related Labeling Changes (SrLCs), Withdrawal of Application Approvals | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) | Office of Program and Strategic Analysis | Remote | Remote | Data Science, Decision Science, Performance Reporting, Policy Evaluation, Program Evaluation | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Medication Error Prevention & Analysis I | Hybrid, Remote | Silver Spring, MD | Human Factors, Labeling, Medication Error Prevention, Postmarketing Programs, Proprietary Naming, Surveillance Methods | Both |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Medication Error Prevention & Analysis II | Hybrid, Remote | Silver Spring, MD | Human Factors, Labeling, Medication Error Prevention, Postmarketing Programs, Proprietary Naming, Surveillance Methods | Both |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Mitigation Assessment & Medication Error Surveillance | Remote | Remote | Medication Error Prevention, Pharmacovigilance, Postmarketing Programs, Safety Signal Identification, Safety Signal Management, Surveillance Methods | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Mitigation Assessment & Medication Error Surveillance, Postmarket Medication Error Team | Hybrid, On-Site, Remote | Silver Spring, MD | Medication Errors, Pharmacovigilance, Postmarketing Programs, Safety Signal Identification, Safety Signal Management, Surveillance Methods | Both |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Mitigation Assessment & Medication Error Surveillance, Postmarket Medication Error Team | Remote | Remote | Medication Errors, Pharmacovigilance, Postmarketing Programs, Safety Signal Identification, Safety Signal Management, Surveillance Methods | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Medication Error Prevention & Risk Management, Division of Mitigation Assessment & Medication Error Surveillance, REMS Assessment Team | Remote | Remote | Public Health, Regulatory Affairs, Regulatory Policy, Risk Evaluation and Mitigation Strategies (REMS), Safety-Related Initiatives | No |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Pharmacovigilance & Epidemiology, Division of Pharmacovigilance I | Hybrid, On-Site, Remote | Silver Spring, MD | FDA Adverse Event Reporting System (FAERS), Pharmacovigilance, Postmarketing Programs, Safety Reporting, Surveillance Methods | Both |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Office of Pharmacovigilance & Epidemiology, Division of Pharmacovigilance II | Hybrid, On-Site, Remote | Silver Spring, MD | FDA Adverse Event Reporting System (FAERS), Pharmacovigilance, Postmarketing Programs, Safety Reporting, Surveillance Methods | Both |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Outreach and Communications Team | Hybrid, On-Site | Silver Spring, MD | Postmarketing Programs, Regulatory Affairs, Regulatory Policy, Safety Reporting, Stakeholder Engagement, Surveillance Methods | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Regulatory Affairs Staff | Hybrid, On-Site | Silver Spring, MD | CDER Manual of Policies & Procedures (MAPP) Development, Citizen Petitions, Guidance Document Development, Inquiry Responses, Postmarketing Programs, Regulatory Affairs, Regulatory Policy, Safety Reporting, Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Stakeholder Engagement | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology (OSE) | Regulatory Science Staff | Remote | Remote | Data Science, Regulatory Science, Safety-Related Initiatives, Safety Reporting | TBD |
| Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD) | Controlled Substances Program | Hybrid, Remote | Silver Spring, MD | Abuse Potential, Behavioral Health, Controlled Substances, Overdose Prevention, Policy Development | Yes |
| Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD) | Counter-Terrorism and Emergency Coordination Staff | Hybrid, On-Site, Remote | Silver Spring, MD | Chemical, Biological, Radiological, and Nuclear (CBRN) Threats, Emergency Coordination, Expanded Access (EA), Incident Command System, Medical Countermeasures | TBD |
| Center for Drug Evaluation and Research (CDER), Office of the Center Director (OCD) | Drug Shortage Staff | Hybrid, On-Site, Remote | Silver Spring, MD | Database Management, Drug Shortages, Regulatory Affairs, Stakeholder Engagement | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology | Hybrid, On-Site, Remote | Silver Spring, MD | Biological Products, Biosimilar Products, Clinical Pharmacology, Product Development | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Division of Cancer Pharmacology I/II | Hybrid, Remote | Silver Spring, MD | Clinical Pharmacology, Oncology, Product Development | Both |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Division of Cardiometabolic & Endocrine Pharmacology | Hybrid, Remote | Silver Spring, MD | Clinical Pharmacology, Product Development | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Division of Infectious Disease Pharmacology | Hybrid, Remote | Silver Spring, MD | Clinical Pharmacology, Clinical Research, Infectious Diseases, Product Development, Review Process | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Division of Inflammation & Immune Pharmacology | Hybrid, On-Site, Remote | Silver Spring, MD | Clinical Pharmacology, Clinical Research, Product Development, Review Process | Both |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Division of Translational & Precision Medicine | Hybrid | Silver Spring, MD | Biologics License Application (BLA), Clinical Pharmacology, Clinical Research, Investigational New Drug (IND) Application, New Drug Application (NDA), Pharmacogenomics, Review Process | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Immediate Office | Hybrid, Remote | Silver Spring, MD | Clinical Pharmacology, Drug Interactions | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Immediate Office, Guidance and Policy Team | Hybrid, On-Site, Remote | Silver Spring, MD | Human Drug Products, Clinical Pharmacology, Diversity, Product Development, Review Process, Guidance & Policy | Yes |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) | Office of Clinical Pharmacology, Immediate Office, Pediatrics Program | Hybrid, On-Site, Remote | Silver Spring, MD | Clinical Pharmacology, Pediatrics, Product Development, Special Populations, Systems Pharmacology | Yes |
| Office of Regulatory Affairs (ORA) | Medical Products Inspectorate (MPI), Office of Human & Animal Drug Inspectorate (OHADI) Division VI | Hybrid | Irvine, CA | Drug Manufacturer Inspections/Investigations/Compliance, Foreign Drug Manufacturer Inspections, Human Drug Products, GDUFA, Drug Quality, Quality Assurance, Current Good Manufacturing Practices (CGMPs), Sterile Drug Compounding, Regulatory Affairs, Recall Operations, Medical Products Laboratory (Micro and Chemical) | Yes |
| Office of Regulatory Affairs (ORA), Office of Import Operations (OIO) | Investigations Branch | Hybrid, On-Site, Remote | Honolulu, HI | Public Health, Quality Assurance, Regulatory Affairs, Regulatory Policy | Yes |
| Office of Regulatory Affairs (ORA), Office of Import Operations (OIO) | Investigations Branch | Hybrid, On-Site, Remote | South San Francisco, CA | Public Health, Quality Assurance, Regulatory Affairs, Regulatory Policy | Both |
| Office of Regulatory Affairs (ORA), Office of Medical Products & Tobacco Operations (OMPTO) | Office of Bioresearch Monitoring Operations | Hybrid, On-Site, Remote | Atlanta, GA | Clinical Trials, Protocol Analysis, Regulatory Policy, Stakeholder Engagement | TBD |
| Office of Regulatory Affairs (ORA), Office of Medical Products & Tobacco Operations (OMPTO) | Office of Bioresearch Monitoring Program | Remote | Remote | Clinical Research Regulations | No |
| Office of Regulatory Affairs (ORA), Office of Medical Products & Tobacco Operations (OMPTO) | Office of Pharmaceutical Quality Operations, Division of Pharmaceutical Quality Operations I | Hybrid | Parsippany, NJ | Current Good Manufacturing Practice (CGMP), Sterile Drug Compounding, Quality Assurance, Regulatory Affairs | TBD |
| Office of Regulatory Affairs (ORA), Office of Medical Products & Tobacco Operations (OMPTO) | Office of Pharmaceutical Quality Operations, Division of Pharmaceutical Quality Operations II | Hybrid | Houston, TX | Drug Manufacturer Inspections/Investigations/Compliance, Foreign Drug Manufacturer Inspections, Human Drug Products, GDUFA, Drug Quality, Quality Assurance, Current Good Manufacturing Practices (CGMPs), Sterile Drug Compounding, Regulatory Affairs, Recall Operations, Medical Products Laboratory (Micro and Chemical) | TBD |
| Office of Regulatory Affairs (ORA), Office of Partnerships & Operational Policy (OPOP) | Office of Policy, Compliance, and Enforcement, Division of Compliance & Enforcement, Recall Operations Branch | Remote | Remote | Import Operations, Investigations, Recall Operations, Regulatory Compliance, Regulatory Enforcement | No |
| Office of the Commissioner (OC), Office of Digital Transformation (ODT) | Office of Health Informatics | Remote | Remote | Database Management, Structured Product Labeling | TBD |
| Office of the Commissioner (OC), Office of Minority Health & Health Equity (OMHHE) | Immediate Office | Hybrid, On-Site, Remote | Silver Spring, MD | Minority Health, Health Disparities, Research, Center Collaboration | Yes |
| Office of the Commissioner (OC), Office of the Chief Scientist (OCS) | Advisory Committee Oversight and Management Staff | On-site, Remote | Silver Spring, MD | Advisory Committee, Regulatory Affairs, Stakeholder Engagement | TBD |
| Office of the Commissioner (OC), Office of Women's Health (OWH) | Immediate Office, Scientific Programs | Remote | Remote | Sex as a Biological Variable, Women's Health | TBD |
| Office of the Commissioner (OC), Oncology Center of Excellence (OCE) | Project Facilitate | Hybrid, Remote | Silver Spring, MD | Drug Review Process, Expanded Access (EA), Regulatory Affairs | TBD |
| Office of the Commissioner (OC), Oncology Center of Excellence (OCE) | Project Orbis | Remote | Remote | Drug Review Process, Global Regulatory Affairs, International Collaboration and Harmonization | Yes |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Immunology and Inflammation/Division of Hepatology and Nutrition | Remote | Remote | New drug approval process and relevant laws & regulations, investigational studies during drug development, prescription drug labeling | TBD |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Generic Drug Policy, Division of Orange Book Publication & Regulatory Assessment | Remote | Remote | Generic Drug Products, Policy Development, Patents, Exclusivities, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of Diabetes, Lipid Disorders, and Obesity | Remote | Remote | Labeling and Safety Analysis of drugs and biologics for the prevention, treatment, or diagnosis of conditions including Type 1 and Type 2 diabetes mellitus, Weight loss and weight maintenance, and Lipodystrophy | TBD |
| Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ) | Office of Program & Regulatory Operations (OPRO) | Remote | Remote | Project Management, Generic Drug Approval Process, Pre market and Post Market review, Regulatory Affairs, Abbreviated New Drug Application (ANDA), Review Process and regulatory letters, drug development | TBD |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs | Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)](Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine-Division of Rare Diseases and Medical Genetics (DRDMG) | FDA) | Hybrid | Silver Spring, MD | Rare diseases, drug development |
| Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ) | Office of Pharmaceutical Assessment III | Remote | Remote | Biologics Price Competition and Innovation Act of 2009 (BPCI Act), Insulin Products, Monoclonal Antibodies, Postmarketing Programs, Regulatory Policy, Therapeutic Proteins | TBD |