Title 21 Vacancy Announcement
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER)
Office of Pharmaceutical Quality (OPQ)
Office of Program and Regulatory Operations (OPRO)
Application Period: April 15, 2024 – April 26, 2024
Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S.
National. Foreign nationals or legal permanent residents are not eligible for consideration.
Commissioned Corp Officers are eligible to apply. Appropriate for O-6 billet.
Position: Supervisory Regulatory Health Project
Manager
Series: AD- 0696
Location(s): Silver Spring, MD
Work Schedule: Full Time
Salary: Starting at $139,395
Cures Band(s): Band D
Full Performance Band Level: Band D
Travel Requirements: 25% or less
Bargaining Unit: 8888
Relocation Expenses Reimbursement: Will not be paid.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the
21st Century Cures Act. The candidate selected for this position will serve under a career or
career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and
consumer protection agency responsible for ensuring all human and animal drugs, medical
devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing
animals, tobacco and radiation emitting devices safe, and effective.
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The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential
public health task by making sure that safe and effective drugs are available to improve the
health of people in the United States. CDER regulates the over the counter (OTC) and
prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of
human pharmaceutical quality within CDER, including submission review, manufacturing facility
assessment, and surveillance of the quality of marketed pharmaceutical products.
The Office of Program and Regulatory Operations (OPRO) is accountable for leading and
coordinating regulatory review processes, facilitating a quality management system, and
maintaining a learning and professional development program in collaboration with review
offices within the OPQ. Specifically, OPRO is responsible for managing all processes associated
with drug product quality review and facility inspections.
The Division of Regulatory & Business Process Management is responsible for leading and
managing all processes associated with drug quality review and facility inspections for all
applications throughout the drug product lifecycle through the coordination with all OPQ
Offices to monitor and track the progress of all internal and cross-functional OPQ projects to
ensure completion on time and conformance to the internal processes and procedures.
Duties/Responsibilities
The Supervisory Regulatory Health Project Manager oversees the operations, functions, and
activities of the organizational unit as carried out by highly trained professional and technical
staff.
• Designs, develops, and implements internal processes to support drug quality
assessment, in collaboration with the other OPQ and CDER offices.
• Leads and participates fully in strategic planning activities concerning the Branch
program segments for pharmaceutical quality assessment.
• Provides technical oversight and guidance pertaining to specific drug regulatory and
quality initiatives.
• Implements initiatives regarding regulatory guidance and project management and
provides on the assessment process and procedures.
Supervisory Responsibilities: Manages multiple projects and provides leadership to personnel
within the branch. Supervises and evaluates staff who serve as experts in their field. Provides
occupational specific technical and administrative direction and supervision 25 percent or more
of the time to subordinate staff performing the work and functions of the organizational unit.
Obtains resources, identifies strategic objectives, and establishes goals for the Branch.
Executes strategic objectives for the organization.
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Conditions of Employment
• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation,
verification of qualifications, completion of onboarding forms, submission of required
documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this
announcement.
• Direct Deposit: You will be required to have all federal salary payments electronically
deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will
be processed through e-Verify to determine your employment eligibility. If a discrepancy
arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959 must be registered with the Selective Service.
• One-year supervisory probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation/Security Clearance is required. All employees must pass a security
investigation. Failing to pass the background check may be grounds for removal or legal
action. If hired, you may be subject to additional investigations at a later time.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use
the basic requirements defined in the OPM Qualification Standards as a baseline
for comparing experience levels and other candidate attributes for relevant
positions.
b. Outstanding candidates can be defined by existing outstanding work experience,
outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required
qualifications. Please note: Additional education and experience listed that is not indicated as
required is preferable and desired. Candidates who do not meet the “desired” criteria will not be
excluded from consideration for this position.
Education and Experience Requirements:
Consumer Safety Officer, 0696
A. A bachelor’s or graduate/higher level degree in quality assurance or a related degree that
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included at least 30 semester hours in one or a combination of the following: consumer laws,
biological sciences, food science, chemistry, pharmacy, physical sciences, food technology,
nutrition, medical science, engineering, epidemiology, veterinary medical science, legal
investigations, law enforcement, or related scientific fields that provided knowledge directly
related to consumer safety officer work.
The 30 semester hours may include up to 8 semester hours in statistics, or course work that
included the principles, theory, or practical application of computers or computer programming
OR
B. Combination of education and experience—courses consisting of at least 30 semester hours in
the fields of study described in paragraph A above, plus appropriate experience or additional
education.
For more information please see: OPM Occupational Series Qualification Requirements.
Desired Professional Experience:
Our ideal candidate will possess:
• Ability to apply knowledge of regulatory assessment process and project management skills.
• Demonstrated managerial experience in a diverse organization.
• Ability to develop networks and build alliances. Experience collaborating cross boundaries to
build strategic relations and achieve common goals.
• Ability to identify internal and external politics that impact the work of the organization.
• Ability to identify and analyze problems, weighing relevance and accuracy of information, in
order to evaluate alternative solutions and make recommendations.
• Experience in organizational change management.
• Ability to effectively and efficiently communicate with various audiences with varying levels of
domain expertise.
• Demonstrated success in implementing information management systems that effectively meet
business needs.
• Ability to work independently and as a contributing, productive, and collaborative team
member.
Education Transcripts
SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often
have very specific educational requirements. A transcript is required to verify educational
achievement. 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 FDA
employee, you are not exempt from transcript requirements.
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.
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education program; or full credit has been given for the courses at a U.S. accredited college or
university. For more information about this requirement, please visit the U.S. Department of
Education website for Foreign Education Evaluation.
Security Clearance Requirements
Background Investigation/Security Clearance Requirements: Non-Sensitive/High Risk
A background security investigation will be required for all appointees. Appointment will be
subject to the applicant’s successful completion of a background security investigation and
favorable adjudication. Failure to successfully meet the requirements may be grounds for
appropriate personnel action. In addition, if hired, a background security investigation or
supplemental investigation may be required later.
Applicants are also advised that all information concerning qualification is subject to
investigation. False representation may be grounds for non-selection and/or appropriate
disciplinary action.
Ethics Clearance Requirements
This position may require financial disclosure reporting and will be subject to FDA's prohibited
financial interest regulation. If you are hired, you may be required to divest of certain financial
interests. You are advised to seek additional information on this requirement from the hiring
official before accepting any job offers. For more information please visit the FDA Ethics web
page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Equal Employment Opportunity
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color,
religion, sex (including pregnancy and gender identity), national origin, political affiliation,
sexual orientation, marital status, disability, genetic information, age, membership in an
employee organization, retaliation, parental status, military service, or other non-merit factor.
Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where
appropriate. Applicants requiring reasonable accommodation for any part of the application
process should follow the instructions in the job opportunity announcement. For any part of
the remaining hiring process, applicants should contact the hiring agency directly.
Determinations on requests for reasonable accommodation will be made on a case-by-case
basis. A reasonable accommodation is any change to a job, the work environment, or the way
things are usually done that enables an individual with a disability to apply for a job, perform
job duties or receive equal access to job benefits.
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Under the Rehabilitation Act of 1973, federal agencies must provide reasonable
accommodations when: An applicant with a disability needs accommodation to have an equal
opportunity to apply for a job. An employee with a disability needs accommodation to perform
the essential job duties or to gain access to the workplace. An employee with a disability needs
accommodation to receive equal access to benefits, such as details, training, and office-
sponsored events. You can request a reasonable accommodation at any time during the
application or hiring process or while on the job. Requests are considered on a case-by-case
basis. Learn more about disability employment and reasonable accommodations or how to
contact an agency.
E-Verify
The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility
Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of
new hires and the validity of their Social Security numbers.
How to Apply
All qualified candidates should submit their resume and transcripts to
[email protected] no later than April 26, 2024.
A resume, not a CV, must be received. You can access the USA Jobs Resume Builder to assist
with building your resume.
If you have foreign transcripts, please submit the foreign transcript course-by-course evaluation
from an accredited company (NACES or AICE). Candidate resumes may be shared with hiring
officials within CDER with a similar job vacancy. Candidates can opt out of this process by
annotating resume with “do not share”.
Please reference Job Reference ID: OPRO: Supervisory Regulatory Health Project Manager in
the subject line.
How You Will Be Evaluated
Candidates may be evaluated based on an interview, review of requested work samples, writing
samples, most recent performance evaluation(s), professional references, results of an oral
presentation or work-related test. Failure to comply with any of the additional assessment
requirements will result in removal from further consideration.
Announcement Contact
For questions regarding this Cures position, please contact
The U.S. Department of Health and Human Services is an equal opportunity employer with a
smoke free environment.
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FDA is an equal opportunity employer.
