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Kyocera Document Solutions America, Inc.
Silver Spring, MD | Other
$109k-143k (estimate)
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DoubleTree by Hilton Washington DC Silver Spring
Silver Spring, MD | Full Time
$75k-102k (estimate)
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Alaka`ina Foundation Family of Companies
Silver Spring, MD | Full Time
$104k-131k (estimate)
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Office of Intramural Training & Education
Silver Spring, MD | Full Time
$76k-101k (estimate)
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HHS Careers is Hiring a Regulatory Counsel Near Silver Spring, MD
SummaryThis 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 2, Band E.
Learn more about this agency
Duties
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-0301-00Education: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution.
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.
OR9 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.EducationPay 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.
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, 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
Additional InformationAdditional Conditions of Employment:
Additional Information
All requirements must be met by the closing date of this announcement (06/28/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.Read more
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above.
This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or 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.Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Learn more about this agency
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.
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
- 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. Please go to http://www.sss.gov for more information.
- One-year probationary period may be required.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
- Background Investigation Requirement: 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.
- Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
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-0301-00Education: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution.
- OR-
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.
OR9 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.EducationPay 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.
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, 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)
Additional InformationAdditional Conditions of Employment:
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- Bargaining Unit: No
- Telework eligible position: Yes
- Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
Additional Information
- Additional selections may be made for similar positions across the Food and Drug Administration (FDA) within the local commuting area(s) of the location identified in this announcement.
- Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
- If you are serving, or have served in the last 5 years (from 06/28/2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.
All requirements must be met by the closing date of this announcement (06/28/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.Read more
- Help
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above.
This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or 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.Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Job Summary
JOB TYPE
Part Time
SALARY
$87k-113k (estimate)
POST DATE
06/24/2024
EXPIRATION DATE
07/22/2024
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The job skills required for Regulatory Counsel include Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Counsel. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Counsel. Select any job title you are interested in and start to search job requirements.
For the skill of Presentation
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The following is the career advancement route for Regulatory Counsel positions, which can be used as a reference in future career path planning. As a Regulatory Counsel, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Counsel. You can explore the career advancement for a Regulatory Counsel below and select your interested title to get hiring information.
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