The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
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 Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ will examine current policies, establish new policies, and identify research needs to ensure that drug quality policies support the availability of quality medicines for all Americans.
Duties/Responsibilities
As Regulatory Counsel, the incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy; that their need is justified, and that scientific and regulatory decisions have been appropriately documented.
Drafts or critically reviews documents embodying policy and program proposals and decisions. These documents state or interpret Center or FDA policy for the regulated industry and other affected groups and receive minimal review before transmittal to Center management.
Directs analyses of proposed changes to agency regulations which affect the programs, functions, and activities of the branch. Implements changes and additions consistent with new legislation or regulations.
Serves as an expert consultant in legal/regulatory matters and is frequently called on to advise others concerning FDA statutes and regulations related to quality.
Prepares and reviews replies to correspondence from the regulated industry, members of Congress, and other interested persons on legal/regulatory issues that are industry-wide in scope or have broad health-policy implications and that concern precedent-setting interpretations of FDA policy.
Supervisory Responsibilities: n/a
Our ideal candidate will possess:
Knowledge of drug law is desired. These laws include, but are not limited to, the Federal Food, Drug, and Cosmetic (FD&C) Act, the Public Health Service Act, the Fair Packaging and Labeling Act, the Federal Anti-Tampering Act, the Orphan Drug Act, the Drug Price Competition and Patent Term Restoration Act, the Drug Export Amendments Act, Government Performance and Results Act, Small Business Regulatory Fairness Act, the Prescription Drugs User Fees Act, etc. Regulations include, but are not limited to, Title 21 of the Code of Federal Regulations.
Demonstrated ability to identify and analyze problems; weigh the relevance and accuracy of information; generate and evaluate alternative solutions; and make recommendations.
Expert ability to communicate and work with staff at all levels of the organization and varying levels of domain expertise; demonstrated ability to collaborate across boundaries to build strategic relationships and achieve common goals.
Ability to work independently and as a contributing, collaborative team member.
Ability to organize time effectively, determine priorities, and move work forward.
Demonstrated success in implementing information management systems that effectively meet business needs.
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 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:
Scientific, Technical, and Professional Fields
Qualified and Outstanding Candidates
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.
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 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. 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.
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.
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.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an 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.
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 are safe, and effective.
The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
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 o...f Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ will examine current policies, establish new policies, and identify research needs to ensure that drug quality policies support the availability of quality medicines for all Americans.
