Posted June 15, 2026
Regulatory Scientific Reviewer (Pharmacist)
FDA Center for Drug Evaluation and Research
Bethesda, MD
Full Time
Reference: FDACenterforDrugEvaluationandResearch872975500
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.
To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.
Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.
Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/pharmacist-series-0660/
Pharmacy Series 0660, Individual Occupational Requirements
Note: Employees currently assigned to positions in this occupational series as of September 2017 will be considered to have met the basic requirements for the position occupied.
Basic Requirements:
Education: A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (https://www.acpe-accredit.org/) (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Licensure: Applicants must be licensed to practice pharmacy in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Experience: Applicant's qualifications background must demonstrate the knowledge, skills, abilities, and competencies necessary to perform the work of the position. Pharmacy work requires knowledge of the use, clinical effects, and composition of medications, including their chemical, biological, and physical properties. Qualifying professional pharmacy experience may involve, but is not limited to: Dispensing medications prescribed by physicians and other health practitioners and providing information to health practitioners and patients about proper usage of medications and side effects; Evaluating medication use patterns and outcomes for patients in hospitals or managed care organizations; Performing administrative, consultative, or staff advisory work for a medical facility's pharmacy program; Planning, monitoring and evaluating medication programs or regimens; Establishing medication-handling procedures for the storage and preservation of medications; Researching medical literature and/or clinical medication information to provide accurate responses to inquiries; and/or, Maintaining all medication records required by law.
Basic Requirements for the GS-13 and above (equivalent to Title 21 Pay Band C and above) Grade Levels: In addition to the licensure and educational requirements described above, a minimum of one year of professional pharmacy experience that is equivalent to at least the next lower grade/band level.
Medical Requirements: Applicants must be able to distinguish basic colors.
AND,
RELEVANT YEARS OF EXPERIENCE: Applicants must meet the following education and relevant experience combination to qualify for this AD-0660, Band C (GS-13 equivalent) position:
A Ph.D., Pharm.D., or equivalent doctoral degree and also have one (1) year of relevant experience as follows: (1) planning and executing complex assignments, resolving technical conflicts, and leading multidisciplinary teams to address high-impact, controversial, or precedent-setting issues within a designated area of expertise; (2) coordinating with internal and external stakeholders to ensure seamless integration with broader regulatory programs; (3) ensuring legal, policy, and technical considerations are adequately identified and addressed; and (4) providing scientific or technical guidance on specialized research initiatives and product-specific protocols.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.
To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.
Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.
Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:
- National Association of Credential Evaluation Services (NACES)
- Association of International Credentials Evaluators (AICE)
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
- Applies expertise in drug formulation, labeling, stability, compounding, drug interactions, and medication use to evaluate the quality, safety, and appropriate use of pharmaceutical products across diverse patient populations.
- Utilizes knowledge of pharmaceutical sciences and clinical pharmacy practice to support science-based assessments of drug products, manufacturing standards, and medication-related policies.
- Serves as an authoritative source of information and advice on matters related to the assigned area of responsibility.
- Analyzes complex data and guidelines or criteria for scientific review and approval for a class of products.
- Identifies risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.
- Mentors junior reviewers.
- Makes recommendations that go to the supervisor, team leads, branch chief, etc. for directors' concurrence.
Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/pharmacist-series-0660/
Pharmacy Series 0660, Individual Occupational Requirements
Note: Employees currently assigned to positions in this occupational series as of September 2017 will be considered to have met the basic requirements for the position occupied.
Basic Requirements:
Education: A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (https://www.acpe-accredit.org/) (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Licensure: Applicants must be licensed to practice pharmacy in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Experience: Applicant's qualifications background must demonstrate the knowledge, skills, abilities, and competencies necessary to perform the work of the position. Pharmacy work requires knowledge of the use, clinical effects, and composition of medications, including their chemical, biological, and physical properties. Qualifying professional pharmacy experience may involve, but is not limited to: Dispensing medications prescribed by physicians and other health practitioners and providing information to health practitioners and patients about proper usage of medications and side effects; Evaluating medication use patterns and outcomes for patients in hospitals or managed care organizations; Performing administrative, consultative, or staff advisory work for a medical facility's pharmacy program; Planning, monitoring and evaluating medication programs or regimens; Establishing medication-handling procedures for the storage and preservation of medications; Researching medical literature and/or clinical medication information to provide accurate responses to inquiries; and/or, Maintaining all medication records required by law.
Basic Requirements for the GS-13 and above (equivalent to Title 21 Pay Band C and above) Grade Levels: In addition to the licensure and educational requirements described above, a minimum of one year of professional pharmacy experience that is equivalent to at least the next lower grade/band level.
Medical Requirements: Applicants must be able to distinguish basic colors.
AND,
RELEVANT YEARS OF EXPERIENCE: Applicants must meet the following education and relevant experience combination to qualify for this AD-0660, Band C (GS-13 equivalent) position:
A Ph.D., Pharm.D., or equivalent doctoral degree and also have one (1) year of relevant experience as follows: (1) planning and executing complex assignments, resolving technical conflicts, and leading multidisciplinary teams to address high-impact, controversial, or precedent-setting issues within a designated area of expertise; (2) coordinating with internal and external stakeholders to ensure seamless integration with broader regulatory programs; (3) ensuring legal, policy, and technical considerations are adequately identified and addressed; and (4) providing scientific or technical guidance on specialized research initiatives and product-specific protocols.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
