- Position Title
- Regulatory Counsel
- Agency
- Food and Drug Administration
- Announcement Number
- FDA-CDER-DE-18-10293012 Opens in new window
- Open Period
- Wednesday, September 26, 2018 to Thursday, October 11, 2018
For preview purposes only. To apply, please return to the USAJOBS announcement and click the Apply button.
Eligibilities
1.
Do you claim Veterans’ Preference?
2.
Do you wish to be considered under a CTAP (Career Transition Assistance Plan) eligibility?
You may qualify for CTAP eligibility if all of the statements apply to you:
To verify your eligibility for CTAP:
You must submit supporting documentation such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action showing position, tenure code, grade & step, and full name/DOB/SSN.
You may qualify for CTAP eligibility if all of the statements apply to you:
- You are located in the same local commuting area of the vacancy.
- You have been (or will be) involuntarily separated from the agency advertising this position, due to a reduction-in-force.
- You are applying to a position that is at (or below) the grade level of the position separated from.
- You are applying to a position that does not have greater promotion potential than the position separated from.
- Your last performance rating of record is at least "fully successful" or equivalent.
To verify your eligibility for CTAP:
You must submit supporting documentation such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action showing position, tenure code, grade & step, and full name/DOB/SSN.
3.
Do you wish to be considered under the Schedule A eligibility for people with disabilities?
You may qualify for this eligibility if you have a severe physical, psychiatric, or intellectual disability, that limits one (or more) of your life functions, and qualifies based on Schedule A provisions. You can read more about Schedule A on the USAJOBS website. Learn more about this eligibility on the Individuals with Disabilities page on USAJOBS...
To verify your eligibility:
You must provide appropriate medical documentation, such as a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition, fitness to work, and any related work restrictions. This documentation must be provided with your application. You will not be able to provide this documentation once the vacancy announcement closes.
You may qualify for this eligibility if you have a severe physical, psychiatric, or intellectual disability, that limits one (or more) of your life functions, and qualifies based on Schedule A provisions. You can read more about Schedule A on the USAJOBS website. Learn more about this eligibility on the Individuals with Disabilities page on USAJOBS...
To verify your eligibility:
You must provide appropriate medical documentation, such as a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition, fitness to work, and any related work restrictions. This documentation must be provided with your application. You will not be able to provide this documentation once the vacancy announcement closes.
4.
Do you wish to be considered under the ICTAP (Interagency Career Transition Assistance Plan) eligibility?
You may qualify for ICTAP if all of the following statements apply to you:
To verify your eligibility for ICTAP:
You must submit a Reduction in Force (RIF) separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action, showing the agency, position held, tenure and appointment codes, and full biographical information (name, DOB, and SSN).
You may qualify for ICTAP if all of the following statements apply to you:
- You are located in the same local commuting area of the position being advertised.
- You were (or will be) separated from a position at an agency outside of the FDA due to a reduction-in-force.
- You are applying to a position that is at (or below) the grade level of the position from which you have been (or will be) separated.
- You are applying to a position that does not have greater promotion potential than the position from which you have been (or will be) separated.
- Your last performance rating of record is at least "fully successful" or equivalent.
To verify your eligibility for ICTAP:
You must submit a Reduction in Force (RIF) separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action, showing the agency, position held, tenure and appointment codes, and full biographical information (name, DOB, and SSN).
Assessment 1
We will evaluate your resume and responses to this Assessment Questionnaire to determine if you are among the best qualified for this position. Your responses are subject to verification and must be supported by your resume and supporting documents.
1.
From the descriptions below, select the one which best demonstrates your experience in meeting the specialized experience requirements for the for the Regulatory Counsel, GS-0301-13.
For each item, select the one response that most accurately describes your current level of experience and capability using the scale below.
2.
Participate in resolving regulatory, scientific, and technical issues.
3.
Provide advice and guidance on the regulatory program segment, function and activities that include providing legal and regulatory advice and counsel to clients.
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
4.
Revise existing or create new innovation policies and regulations.
For each item, select the one response that most accurately describes your current level of experience and capability using the scale below.
5.
Evaluate proposed legal actions regarding compliance with regulatory requirements.
6.
Evaluate the impact of existing laws and new or revised legislation and regulations.
7.
Research regulatory issues of a wide public interest.
8.
Develop and/or review proposal for new policy statements that impact regulatory policy.
9.
Prepare correspondence replies form the regulated community on issues within the regulated industry.
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
10.
Review documents embodying policy and programs proposals and decision on drug products.
For each item, select the one response that most accurately describes your current level of experience and capability using the scale below.
11.
Draft documents that state or interprets Food and Drug Administration policy to be used within the regulated industry and medical community.
12.
Resolve regulatory issues of a wide public interest.
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
13.
Provide advice on the legal sufficiency and procedural adequacy of proposed policies and initiatives.
14.
Resolve regulatory issues of a wide public interest.
15.
Make oral presentations to recommend changes to programs and procedures to management officials and major stakeholders within the organization at different levels to work on issues, goals and objectives.