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Regulatory Counsel
4 months ago
**Duties**:
- Serves as a principal advisor to the Associate Commissioner for Policy and other FDA and HHS officials regarding FDA's development of regulations, guidance documents, and other policy materials as they relate to FDA programs.
- Conducts sophisticated analyses of complex regulatory and policy issues and works on policy issues of national scope and significance.
- Leads working groups of scientific, regulatory, and legal experts to review relevant legislation.
- Responds to requests from Congress, and implement new statutory authority that has implications for FDA programs which includes medical products, foods, and cosmetics.
- Provides technical advice and guidance to FDA program staff regarding good regulatory practice.
- Represents FDA at meetings or conferences with other government agencies, regulated industry, or other interested or affected communities.
**Requirements**:
**Conditions of Employment**:
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- 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.
- One-year probationary period may be required.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
**Qualifications**:
**Introduction**:
- **_In order to qualify for the _**Regulatory Counsel **_position which falls under the _**0301 **_occupational Series, you must meet the following _**requirements by 11:59 pm EST on **06/28/2024**_:_**
**Minimal Qualifications Requirements for the Regulatory Counsel, AD-0301-00**
Education: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution.
- **-OR-**
Comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products.
- **In addition, to qualify for the Band E level, applicants must meet the qualification requirements below.**
Law degree, specifically a **LL.M. or J.D. degree** and also have **3 years of relevant experience **in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies.
- **OR**
**9 years of relevant experience **in handling regulatory issues, relevant experience could include, but is not limited to experience in a law firm, FDA-regulated industry, or government or non-governmental setting, such as by writing or commenting on regulations; preparing or responding to petitions; drafting or commenting on legislation; or providing advice on the interpretations of laws, regulations, and policies.
- **NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Minimum/Education Requirements.**
**Education**:
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.**
**_See the _**_Application Manager Documentation_**_ for tips on submitting your paper-based documents._**
**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, vis
