FDA Jobs Near Me – Regulatory Counsel

About the job

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 the authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

View full vacancy announcement here: https://www.fda.gov/media/161475/download

Application Period: September 9, 2022 – October 7, 2022

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.

Position: Regulatory Counsel

Series: AD-0301

Location(s): Silver Spring, MD

Work Schedule: Full Time

Salary: Starting at $126,233 to maximum of $193,924

Cures Band(s): Band D

Full Performance Band Level: Band D

Travel Requirements: 25% of less

Bargaining Unit: 3591

Relocation Expenses Reimbursement: Relocation expenses will not be reimbursed.

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 over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

The mission of the Office of Generic Drugs (OGD) and its sub offices are to ensure high-quality, affordable generic drugs are available to the American public. OGD is the world leader in the science and regulation of generic drugs serving an essential role in advancing FDA’s public health mission.

The Office of Generic Drug Policy (OGDP) serves as the Agency’s lead on generic drug policy and regulation to enable generic drug approvals and provide the public with high quality, affordable medicines. We achieve this by advocating on behalf of the generic drug program and providing counsel in a complex, ever-changing legal and regulatory environment.

The Division of Legal and Regulatory Support (DLRS) mission is to advise the OGD on generic drug application specific legal regulatory and policy issues during FDA implementation of Section 505(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The DLRS is responsible for providing expertise on generic drug regulatory issues at both the Center and Agency level.

The Division of Policy Development (DPD) mission is to provide strategic leadership and direction in the development, clearance, and implementation of regulations, guidance, policies, procedures, and other documents affecting the regulation of generic drug products. The DPD collaborates with all FDA offices supporting the generic drug program to ensure timely implementation and fulfillment of FDA’s commitments pursuant to the Generic Drug User Fee Amendments (GDUFA).

The Regulatory Counsel positions are located within OGDP’s Division of Legal and Regulatory Support and Division of Policy Development.

Duties/Responsibilities

As a Regulatory Counsel, the incumbent develops policies and programs involving the most complex and highest priority matters affecting the regulation of generic drug products. Drafts or critically reviews documents that state or interpret Center or FDA policy for the regulated industry and other effected groups, embodying policy and program proposals and decisions on these products.

• Reviews policy and other regulatory documents drafted by other offices that impact generic drug regulation. Drafts revisions and technical corrections to new and existing regulatory documents.
• Serves as an expert consultant on the generic drug regulatory review process within FDA and to other interested groups.
• Reviews petitions and other correspondence from the regulated industry and other interested persons that raise issues that have an effect on the generic industry and FDA’s regulation of generic drug products. Leads and coordinates the Office consult response to correspondence and petitions, and clearance of, these petitions.
• Manages and resolves a broad range of issues concerning the implementation of FDA’s enabling statutes, including those related to generic drug regulation and the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act, pertinent regulations, guidance documents, standard operating procedures, and other policy documents related to the regulation of generic drug products.
• Researches and resolves regulatory issues related to information that is published in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

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
3. 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.
4. 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 Requirement:

Regulatory Counsel, AD-0301 Series

There are no Individual Occupational Requirements for this series. For more information, please see: OPM Occupational Series Qualification Requirements.

Desired Education:

Degree: A juris doctorate degree from an accredited institution of higher learning.

Professional Experience:

Our ideal candidate will possess:

• Knowledge of federal regulatory programs is required; knowledge of drug law is desired.
• Significant experience leading projects independently with minimal supervision is desired.
• Possession of significant knowledge of regulatory practice, policies, and procedures, with experience related to the Hatch-Waxman Amendments and the generic drug program highly desired.
• 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.

Desired Professional Experience:

Our ideal candidate will possess: 5 years’ experience in an attorney or regulatory professional role providing advice on federal regulatory issues. Experience practicing food and drug law in a law firm, government agency, or in-house in the pharmaceutical industry is highly desired.

How to Apply

How to Apply:

Submit resume or curriculum vitae with cover letter by October 7, 2022, to: [email protected] Candidate resumes may be shared with hiring official within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact the OGD Recruitment Team at: [email protected]

Announcement Contact

For questions regarding this Cures position, please contact the OGDP PMAS Team at: [email protected]

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.