- Position Title
- Regulatory Counsel
- Agency
- Food and Drug Administration
- Announcement Number
- FDA-CBER-MP-20-10728836AH Opens in new window
- Open Period
- Monday, February 24, 2020 to Friday, February 28, 2020
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).
5.
Do you wish to be considered under an Interchange Agreement eligibility?
If you are a current Excepted Service employee of an agency with a valid interchange agreement with the Office of Personnel Management you may quality for this eligibility type.
To verify your eligibility:
You must submit a copy of your most recent SF-50: Notification of Personnel Action reflecting your employment status, appointment type, tenure, position information, and full biographic data.
If you are a current Excepted Service employee of an agency with a valid interchange agreement with the Office of Personnel Management you may quality for this eligibility type.
- Postal Career Service Employees
- Postal Rate Commission Employees
- Government Accountability Office (GAO) Employees
- Administrative Office of the U.S. Courts Employees
To verify your eligibility:
You must submit a copy of your most recent SF-50: Notification of Personnel Action reflecting your employment status, appointment type, tenure, position information, and full biographic data.
6.
Are you an employee of a Land Management Agency or a Defense Base Facilities Management Agency?
The Land Management Flexibilities Act allows certain land and base management employees to compete with other status candidates for positions advertised via Merit Promotion.
You may qualify under the Land Management eligibility type if you are a current (or former) employee of a land management or base management agency, and all of the statements below apply to you:
Department of Agriculture: Forest Service
Department of Interior: Bureau of Land Management, National Park Service, Fish & Wildlife Service, Bureau of Indian Affairs, and Bureau of Reclamation.
Department of Defense, Defense Industrial Base Facility or Defense Major Range & Test Facilities Base
To verify your eligibility:
You must provide a copy of your latest SF-50 Notification of Personnel Action and performance appraisal that demonstrate you meet the requirements outlined in the Land Management Workforce Flexibility Act.
The Land Management Flexibilities Act allows certain land and base management employees to compete with other status candidates for positions advertised via Merit Promotion.
You may qualify under the Land Management eligibility type if you are a current (or former) employee of a land management or base management agency, and all of the statements below apply to you:
- You were originally hired to a time-limited position under a competitive appointment.
- You served one (or more) time-limited appointments at a land management agency, for a period totaling more than 24 months, without a break in service of two or more years.
- You performed at an "acceptable" level of service during each period of service.
- You are no longer employed by the land management agency, have been separated for not more than two years, and departed the position in good standing.
Department of Agriculture: Forest Service
Department of Interior: Bureau of Land Management, National Park Service, Fish & Wildlife Service, Bureau of Indian Affairs, and Bureau of Reclamation.
Department of Defense, Defense Industrial Base Facility or Defense Major Range & Test Facilities Base
To verify your eligibility:
You must provide a copy of your latest SF-50 Notification of Personnel Action and performance appraisal that demonstrate you meet the requirements outlined in the Land Management Workforce Flexibility Act.
7.
Are you applying based on a National Service Organization eligibility?
You may be eligible if you have at least two years of service with the Peace Corps or one year of service with AmeriCorps VISTA.
Your non-competitive eligibility lasts for one year after completing your Peace Corps or AmeriCorps service. Federal agencies may extend the period for up to three years if, after your completed service, you are:
Learn more about hiring options for Peace Corps and AmeriCorps Vista alumni.
To verify your eligibility:
You must submit a copy of your description of service or other proof of non-competitive eligibility.
If you are a former Peace Corps volunteer or VISTA member who is requesting an extension of your non-competitive eligibility, please also provide the necessary documentation to support your request.
You may be eligible if you have at least two years of service with the Peace Corps or one year of service with AmeriCorps VISTA.
Your non-competitive eligibility lasts for one year after completing your Peace Corps or AmeriCorps service. Federal agencies may extend the period for up to three years if, after your completed service, you are:
- In the military service.
- Studying at a recognized institution of higher learning.
- Involved in another activity, which in the agency's view, warrants an extension.
Learn more about hiring options for Peace Corps and AmeriCorps Vista alumni.
To verify your eligibility:
You must submit a copy of your description of service or other proof of non-competitive eligibility.
If you are a former Peace Corps volunteer or VISTA member who is requesting an extension of your non-competitive eligibility, please also provide the necessary documentation to support your request.
8.
HHS Public Health Service Officers
Are you a current Commissioned Officer within the Public Health Service and stationed at a position at a Federal agency or department?
If so, you may qualify for non-competitive re-assignment to this position. Current PHS Commissioned Officers can be non-competitively appointed to an open position within HHS, if you are found qualified and if the Hiring Manager agrees to the appointment. You will be required to provide a copy of your most recent orders at the time of application.
Are you a current Commissioned Officer within the Public Health Service and stationed at a position at a Federal agency or department?
If so, you may qualify for non-competitive re-assignment to this position. Current PHS Commissioned Officers can be non-competitively appointed to an open position within HHS, if you are found qualified and if the Hiring Manager agrees to the appointment. You will be required to provide a copy of your most recent orders at the time of application.
9.
Do you wish to be considered for eligibility as a Competitive Merit Promotion, Reassignment, Reinstatement, or Transfer?
You may qualify for this eligibility if any of the conditions below apply to you:
If you are applying under this eligibility as a current or former Federal employee you must submit a copy of your SF-50: Notification of Personnel Action or equivalent personnel action form reflecting your permanent, competitive status. Your SF-50 (or equivalent personnel action form) must reflect: career or career-conditional (Tenure field is 1 or 2); AND status in the competitive service (Position Occupied field is 1).
If you are applying using preference eligible Veteran status, you may want to additionally include your DD-214, if your submitted SF-50 is blank in Field 23 (Veteran Preference Status) or shows a 1.
You may qualify for this eligibility if any of the conditions below apply to you:
- You are currently employed as a Federal civilian employee in the Competitive Service and you've never held the full performance level of the position being advertised.
- You are currently employed as a Federal civilian employee in the Competitive Service and hold a career or career-conditional appointment at a lower grade level than the position being advertised.
- You were formerly employed as a Federal civilian employee, on a permanent competitive appointment, and you have never held the full performance level of the position being advertised.
- You were formerly employed as a Federal civilian employee, obtained career-conditional status, are within 3 years from the date of separation, and, you've never held the full performance of the position being advertised.
- You were employed as a Federal civilian employee, on a career or career-conditional appointment, are a preference eligible Veteran, and have never held the full performance level of the position being advertised.
If you are applying under this eligibility as a current or former Federal employee you must submit a copy of your SF-50: Notification of Personnel Action or equivalent personnel action form reflecting your permanent, competitive status. Your SF-50 (or equivalent personnel action form) must reflect: career or career-conditional (Tenure field is 1 or 2); AND status in the competitive service (Position Occupied field is 1).
If you are applying using preference eligible Veteran status, you may want to additionally include your DD-214, if your submitted SF-50 is blank in Field 23 (Veteran Preference Status) or shows a 1.
10.
Do you wish to be considered for eligibility as a Non-Competitive Merit Promotion, Reassignment, Reinstatement, or Transfer?
You may quality for this eligibility type if any of the following statements apply to you:
You must submit a copy of your SF-50: Notification of Personnel Action (or an equivalent personnel action form) reflecting your permanent, competitive status.
Your SF-50 (or other document) must reflect the following.
You may quality for this eligibility type if any of the following statements apply to you:
- You are a current Federal employee, in the Competitive Service, at the same (or higher) grade level, with the same (or higher) promotion potential, as this announcement.
- You are a current Federal employee, and hold (or have previously held) a career or career-conditional position, at the same (or higher) grade level with the same (or higher) promotion potential, as this announcement.
- You were formerly employed as a Federal civilian employee on a permanent competitive appointment and have held the same (or higher) grade, with the same (or higher) promotion potential, as this announcement.
- You previously obtained career-conditional status, and your separation date is within the last 3 years, and you held a position with the same (or higher) promotion potential, as this announcement.
- You previously obtained career-conditional status, and you are a preference eligible candidate, and you held a position with the same (or higher) promotion potential, as this announcement.
You must submit a copy of your SF-50: Notification of Personnel Action (or an equivalent personnel action form) reflecting your permanent, competitive status.
Your SF-50 (or other document) must reflect the following.
- career or career-conditional (Tenure field is 1 or 2); AND
- status in the competitive service (Position Occupied field is 1).
11.
Are you a qualifying military spouse eligible for non-competitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, Schedule A persons with disabilities, Veterans Recruitment Authority (VRA), military spouse, and PHS Commissioned Corps Officers. This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.
Visit the Family Member Preference (FedsHireVets) or Military Spouses (USAJOBS) pages for more information...
(1) Spouse of Active Duty Service Member with Permanent Change of Station (PCS) Orders
You may quality if you are the spouse of a service member with PCS orders, if all of the following conditions are true:
As a military spouse, you may be eligible to be considered if either of the following statements applies:
(3) Spouse of Service Member Fallen in Duty
You may be eligible as the spouse of a military member who was killed while on active duty, and you have not re-married since the death. The service member's death while on active duty does not need to be combat related for the spouse to qualify.
To verify your eligibility for group 1 identified above:
You must submit a copy of the PCS orders of your spouse.
To verify your eligibility for groups 2 and 3 identified above:
You must submit the SF-15: Application for 10-Point Veteran Preference, and all supporting documentation identified on that document e.g., DD-214: Certificate of Release or Discharge from Active Duty (Member #4 Copy indicating character of service) or other proof of service which includes character of service; death certificate, and documentation identifying marital status at the time of death; disability letter from the Department of Veterans Affairs or Armed Service, etc.
For more information about military spouse eligibility, please see the FedsHireVets Spouse site.
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, Schedule A persons with disabilities, Veterans Recruitment Authority (VRA), military spouse, and PHS Commissioned Corps Officers. This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.
Visit the Family Member Preference (FedsHireVets) or Military Spouses (USAJOBS) pages for more information...
(1) Spouse of Active Duty Service Member with Permanent Change of Station (PCS) Orders
You may quality if you are the spouse of a service member with PCS orders, if all of the following conditions are true:
- You have been married to the military member, on or prior to, the date of your spouse's PCS orders.
- You have not previously been appointed using this authority, under these orders.
As a military spouse, you may be eligible to be considered if either of the following statements applies:
- The military member was retired under Chapter 61, of Title 10, United States Code, with a disability rating of 100 percent from the military.
- The military member was released from active duty and has a disability rating of 100 percent from the Department of Veterans Affairs or the military department.
(3) Spouse of Service Member Fallen in Duty
You may be eligible as the spouse of a military member who was killed while on active duty, and you have not re-married since the death. The service member's death while on active duty does not need to be combat related for the spouse to qualify.
To verify your eligibility for group 1 identified above:
You must submit a copy of the PCS orders of your spouse.
To verify your eligibility for groups 2 and 3 identified above:
You must submit the SF-15: Application for 10-Point Veteran Preference, and all supporting documentation identified on that document e.g., DD-214: Certificate of Release or Discharge from Active Duty (Member #4 Copy indicating character of service) or other proof of service which includes character of service; death certificate, and documentation identifying marital status at the time of death; disability letter from the Department of Veterans Affairs or Armed Service, etc.
For more information about military spouse eligibility, please see the FedsHireVets Spouse site.
12.
VETERANS PREFERENCE INFORMATION
The vacancy you are applying to is being advertised under Delegated Examining (Category Rating) procedures, in accordance with Title 5 of the US Code. Veterans and certain military spouses are able to receive a preference eligibility based on prior military service, disability, or survivorship. You can read more about each eligibility option by clicking the links below. If you answer "yes" to this question, you are indicating that you have read and understand the supporting documentation requirements, and that you will provide these supporting documents in your application. Missing or inaccurate supporting documents may result in your preference claim being adjudicated as ineligible. It's very important that you make the correct selection and provide the required information and documentation for us to verify any claim you submit.
There are three types of Veterans Preference:
For positions advertised under the government-wide merit promotion procedure, preference eligible veterans and qualifying spouses are entitled to apply to the position, but will otherwise receive no additional preference or special placement. Veterans preference allows candidates to be considered for these government-wide advertisements that would otherwise have been restricted to current federal employees.
See the FedsHireVets Job Seekers page for more information on how preference is applied, how to claim a preference, and what documentation you may need to supply.
You can also check out the USAJOBS Veterans site as well.
Having reviewed this information, do you intend to claim any kind of spousal or veterans preference in your application to this announcement?
The vacancy you are applying to is being advertised under Delegated Examining (Category Rating) procedures, in accordance with Title 5 of the US Code. Veterans and certain military spouses are able to receive a preference eligibility based on prior military service, disability, or survivorship. You can read more about each eligibility option by clicking the links below. If you answer "yes" to this question, you are indicating that you have read and understand the supporting documentation requirements, and that you will provide these supporting documents in your application. Missing or inaccurate supporting documents may result in your preference claim being adjudicated as ineligible. It's very important that you make the correct selection and provide the required information and documentation for us to verify any claim you submit.
There are three types of Veterans Preference:
- 10-point preference for Vets with a service-connected disability rating of 30% (or more)
- 5-point preference for Vets with qualifying service (determined by length of service, campaigns, or awards)
- 0-point sole survivor preference for certain spouses of a disabled or deceased veteran
For positions advertised under the government-wide merit promotion procedure, preference eligible veterans and qualifying spouses are entitled to apply to the position, but will otherwise receive no additional preference or special placement. Veterans preference allows candidates to be considered for these government-wide advertisements that would otherwise have been restricted to current federal employees.
See the FedsHireVets Job Seekers page for more information on how preference is applied, how to claim a preference, and what documentation you may need to supply.
You can also check out the USAJOBS Veterans site as well.
Having reviewed this information, do you intend to claim any kind of spousal or veterans preference in your application to this announcement?
13.
Are you a Veteran eligible under the Veteran's Employment Opportunities Act of 1998 (VEOA)?
Veterans Employment Opportunity Act of 1998, as amended (VEOA) is a competitive service appointing authority that can only be used when filling permanent, competitive service positions. It cannot be used to fill excepted service positions. It allows veterans to apply to announcements that are only open to so called "status" candidates, which means "current competitive service employees." Current or former Federal employees meeting VEOA eligibility can apply. However, current employees applying under VEOA are subject to time-in- grade restrictions like any other General Schedule (GS) employee. You can read more about VEOA by clicking this link (opens the FedsHireVets website in a new window).
To be eligible for a VEOA appointment, your latest discharge must be issued under honorable conditions (this means an honorable or general discharge), AND you must be either:
You must provide acceptable documentation of your preference or appointment eligibility. The Member #4 Copy of your DD-214 (Certificate of Release or Discharge from Active Duty) is preferred. If you are additionally claiming a 10-pt preference, you should also submit your VA Letter and SF-15 (Application for 10-Point Veteran Preference).
Veterans Employment Opportunity Act of 1998, as amended (VEOA) is a competitive service appointing authority that can only be used when filling permanent, competitive service positions. It cannot be used to fill excepted service positions. It allows veterans to apply to announcements that are only open to so called "status" candidates, which means "current competitive service employees." Current or former Federal employees meeting VEOA eligibility can apply. However, current employees applying under VEOA are subject to time-in- grade restrictions like any other General Schedule (GS) employee. You can read more about VEOA by clicking this link (opens the FedsHireVets website in a new window).
To be eligible for a VEOA appointment, your latest discharge must be issued under honorable conditions (this means an honorable or general discharge), AND you must be either:
- a preference eligible (defined in title 5 U.S.C. 2108(3)), OR
- a veteran who substantially completed 3 or more years of active service.
You must provide acceptable documentation of your preference or appointment eligibility. The Member #4 Copy of your DD-214 (Certificate of Release or Discharge from Active Duty) is preferred. If you are additionally claiming a 10-pt preference, you should also submit your VA Letter and SF-15 (Application for 10-Point Veteran Preference).
14.
Are you claiming eligibility as a Compensable Disabled Veteran?
You may qualify for this eligibility if you are a veteran, who served at any time, and either of the following statements apply to you:
To verify your eligibility:
You must submit a copy of your latest DD-214: Certificate of Release or Discharge from Active Duty, (Member #4 copy, indicating character of service) or other proof of your service which includes character of service.
You must also submit the disability letter from the Department of Veterans Affairs or Armed Service and the SF:15: Application for 10-Point Veteran Preference.
For more information, please see the FedsHireVets 30% Disabled page...
You may qualify for this eligibility if you are a veteran, who served at any time, and either of the following statements apply to you:
- You have service-connected disability rating of at least 30% from the Department of Veterans Affairs.
- You have been awarded the Purple Heart.
To verify your eligibility:
You must submit a copy of your latest DD-214: Certificate of Release or Discharge from Active Duty, (Member #4 copy, indicating character of service) or other proof of your service which includes character of service.
You must also submit the disability letter from the Department of Veterans Affairs or Armed Service and the SF:15: Application for 10-Point Veteran Preference.
For more information, please see the FedsHireVets 30% Disabled page...
Preferences
1.
In the last five years, based on the closing date of this announcement, have you served or are you currently serving as an Executive Branch political, Schedule C, or Non-career SES appointee?
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.
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.
- A political appointee is an appointment made by the President without confirmation by the Senate (5 CFR 213.3102(c)) OR an assistant position to a top-level federal official if filled by a person designated by the President as a White House Fellow (5 CFR 213.3102(z)).
- A Schedule C appointee occupies a position excepted from the competitive service by the President, or by the Director of OPM, because of the confidential or policy-determining nature of the position duties (5 CFR 213.3301 and 5 CFR 213.3302).
- A Non-career SES appointee is approved by the White House and serves at the pleasure of the appointing official without time limitations (5 CFR 317 Subpart F).
2.
===== Acknowledgement of Restrictions on the Employment of Relatives by Public Officials =====
5 U.S. Code, § 3110 lays out specific and important restrictions on the employment of relatives within an agency.
A public official of a government agency may not appoint, promote, or otherwise advocate for the employment, advancement, or promotion of relatives within the agency for which the public official is employed or has control over.
Employees hired in violation of 5 U.S. Code, § 3110 will not be entitled to any pay for their period of employment, and any pay already received before the violation becomes known, will be considered as a debt to the government on the part of the employed individual.
For the purpose of this question, a "relative" is defined as: father, mother, son, daughter, brother, sister, uncle, aunt, first cousin, nephew, niece, husband, wife, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, stepfather, stepmother, stepson, stepdaughter, stepbrother, stepsister, half brother, or half sister.
QUESTION:
After having read the definition of "relative" as stated above, does the Food and Drug Administration employ any of your relatives?
IF YES: You must provide the following information, for each relative employed by the FDA:
- The full legal name of the relative.
- The relative's relationship to you (from the list above).
- If known, the relative's employing organization and position.
3.
Your responses to the all questions, and any information or documentation which you provide as part of your application, will be thoroughly reviewed for accuracy and truthfulness. Please take this opportunity to review your responses to ensure their accuracy. If you fail to answer this question, your application will not be considered. Knowingly providing false information in your application (or submitted documentation) is a crime!
- I certify that, to the best of my knowledge and belief, all of the information included in my application is true, correct, and provided in good faith.
- I understand that if I intentionally make a false statement, or commit deception or fraud in my application, or in any document or interview associated with the examination process, I may be fined or imprisoned (18 USC, Sec 1001); my eligibility may be canceled, I may be denied an appointment, or I may be removed and debarred from Federal service (5 CFR, Part 731).
- I understand that any information I provide may be investigated.
- I understand that responding "No" to this item will result in my not being considered for this position.
Assessment 1
If after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
1.
From the description below, select the one which best describes your experience and meets the Minimal Qualification Requirement for the Regulatory Counsel GS-0301-14.
For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Please select only one letter for each item.
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
2.
Resolve issues concerning the application of any of FDA's enabling legislation, pertinent regulations and/or general legislation affecting the operation of the FDA, particularly with respect to the Public Health Service Act and Federal Food Drug and Cosmetic Act.
3.
Develop policies and program involving the most complex and highest priority matters affecting the regulation of biological products and related issues.
4.
Resolve issues concerning the application of any of FDA's enabling legislation, pertinent regulations and/or general legislation affecting the operation of the FDA, particularly with respect to the Public Health Service Act and Federal Food Drug and Cosmetic Act.
5.
Serve as an expert consultant on the regulatory process to Divisions within the Office of the Center Director and other Agency component.
6.
Draft or review proposals for new regulations and policy statements involving biological products.
7.
Develop petition responses, regulatory documents, and other written statements, policies, and consult with staff at all levels to identify areas of disagreements between Agency components and work to resolve disagreements through the use of memoranda or through meetings and articulate any policy consensus reached through this process.
8.
Review, summarize and draft response to public comments received on proposed regulations, guidance's, or policy documents and make recommendations regarding the adoption or rejection of any counter-proposal.
9.
Draft or review proposals for new regulations and policy statements involving biological products.
10.
Serve as the leader or participant of a working group related to such matters and as such will be expected to advise others with respect to FDA statutes and regulations and related matters processes.
11.
Respond to correspondence/inquiries from the regulated industry and other interested person on issues that are industry-wide in scope or have brad health policy implications and that concern precedent setting interpretation FDA policy.
12.
Advise other offices on procedures and methods for implementing new regulations and revising existing regulations as well as the legal sufficiency and procedural adequacy of proposed policy states and policy initiatives.
13.
Presents at conferences and professional meetings before staff and regulated industry on the applicable regulations and policies.