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Regulatory Counsel

Company: Food and Drug Administration
Location: Silver Spring
Posted on: May 19, 2019

Job Description:

Regulatory Counsel==================##### Department of Health And Human ServicesFood and Drug Administration##### Center for Drug Evaluation and ResearchOverview--------- ##### Open & closing dates05/14/2019 to 05/28/2019- ##### ServiceCompetitive- ##### Pay scale & gradeGS 14- ##### Salary$117,191 to $152,352 per year- ##### Appointment typePermanent- ##### Work scheduleFull-TimeLocation---------Silver Spring, MD Many vacancies##### Relocation expenses reimbursedYes You may qualify for reimbursement of relocation expenses inaccordance with agency policy.##### Telework eligibleYes as determined by agency policy- Duties------### Summary**This position is located in the Department of Health and HumanServices (DHHS), Food and Drug Administration (FDA), Center for DrugEvaluation and Research (CDER), Office of Compliance (OC), Office ofManufacturing Quality (OMQ), located in Silver Spring, MD.**Learn more about this agency### Responsibilities- Develop policies and programs involving complex and highpriority matters affecting the regulations of drug products.- Lead working groups of scientific regulatory and legal expertsto develop new or revised regulations and draft the resultingnotices of proposed rule making.- Draft and comment on proposed legislation on matters pertainingto FDA?s jurisdiction.- Consult with appropriate scientific experts and draft responsesto citizen petitions, petitions for stay of action, and/orpetitions for reconsideration.- Advise staff in the office of Chief Counsel and other offices inthe Office of Commissioner on matters related to the RegulatoryCounsel's responsibilities.### Travel RequiredNot required##### Supervisory statusNo##### Promotion Potential14- #### Job family (Series)0301 Miscellaneous Administration And Program- Requirements------------### Conditions of Employment- Citizenship Requirement: You must be a U.S. Citizen to beconsidered for this advertisement unless explicitly statedotherwise.- Selective Service Registration: All applicants born male, on (orafter) 12/31/1959, must be registered with the Selective ServiceSystem OR have an approved exemption. Visit for moreinfo.- FDA participates in e-Verify: All new hires must complete theI-9 form; this information will be processed through e-Verify todetermine your employment eligibility. If a discrepancy arises,you must take affirmative steps to resolve the matter.- Background Investigation Requirement: All employees must pass asecurity investigation. Failing to pass the background check maybe grounds for removal or legal action. If hired, you may besubject to additional investigations at a later time.- Time-in-Grade Requirement: If you are applying as a currentFederal employee, you must meet the time-in-grade requirementsdescribed in the Qualifications section, generally, 52-weeks ofcomparable experience at the next lowest grade.- You must meet ALL requirements by the closing date of thisannouncement to be considered. Only education, experience, andqualifications attained by this date will be considered. Youmust continue to meet all requirements through the hiringprocess.- Certification of Accuracy: All information concerningeligibility and qualification is subject to investigation andverification. False representation may be grounds fornon-consideration, non-selection, or appropriate legal action.- Direct Deposit: You will be required to have all federal salarypayments electronically deposited into a bank account with afinancial institution of your choice.- Additional selections may be made from this vacancy, within thesame geographical area, by other organizational elements fromwithin FDA, through shared corporate recruiting activities.### Qualifications**The position of Regulatory Counsel falls under the** **0301****occupational series. To qualify for this position at grade**GS-**14, you must meet Time-in-Grade requirements by 11:59 pm EST on05/28/2019.**GS-14: Applicants must have one year specialized experience to theGS-13 grade level in the Federal Service that has equipped me withthe particular skills, knowledge, and ability to successfullyperform the duties of the position. Such experience includes writingregulations related to drug products for regulated industry andproviding advice on the interpretation of drug products regulationsand policies.In accordance with Office of Personnel Management policy, federalemployees are assumed to have gained experience by performing dutiesand responsibilities appropriate for their official series and gradelevel as described in their position description. Experience thatwould not normally be part of the employee's position is creditable,however, when documented by satisfactory evidence, such as a signedmemorandum from the employee's supervisor or an SF-50 or SF-52documenting an official detail or other official assignment. Thedocumentation must indicate whether the duties were performed fulltime or, if part time, the percentage of times the other duties wereperformed. It is expected that this documentation is included in theemployee's official personnel record. In order to receive credit forexperience in your resume that is not within the official series andgrade level of your official position, you must provide a copy ofthe appropriate documentation of such experience as indicatedabove.Who May Apply:- Federal employees with career or career-conditionalappointments in the competitive service;- Former Federal employees with reinstatement eligibility based onprevious career or career-conditional appointments;- Displaced Federal employees requesting special priority selectionconsideration under the Career Transition Assistance Plan (CTAP) orthe Interagency Career Transition Assistance Program (ICTAP);- Veterans who are preference eligibles or who have been separatedunder honorable conditions after 3 years or more of continuousactive service;- Military Spouses;- PHS Commissioned Corps Officers;- Individuals eligible for VEOA appointments (at the GS-11 and abovegrade levels);- Individuals with disabilities who quality for a Schedule Aappointment.PHS Commissioned Corps Officers interested in performing the dutiesof this position within the Commissioned Corps may apply online tothis announcement. Candidates will be referred to (CC) personnel andnot as candidates for conversion to a permanent career orcareer-conditional appointment.If you are applying based on some other qualifying eligibility ( are not applying as a current Federal employee), you must meetthe specific requirements of the eligibility you are claiming, andmust have sufficient past experience to demonstrate that you areminimally qualified for this position. *See Unique Hiring Paths onUSAJOBS for more information about various ways you may be eligibleto apply!***NOTE:** It is your responsibility to ensure your responses andappropriate documentation is submitted prior to the closing date. Toverify your application is complete, log into your USAJOBS account,, select the **ApplicationStatus** link and then select the M**ore Information** link for thisposition. The Details page will display the status of yourapplication, the documentation received and processed, and anycorrespondence the agency has sent related to this application. Youruploaded documents may take several hours to clear the virus scanprocess.**To return to an incomplete application**, log into your USAJOBSaccount and click **Update Application** in the vacancyannouncement. You must re-select your resume and/or other documentsfrom your USAJOBS account or your application will be incomplete.**IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WEWILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualificationsare based on breadth/level of experience. In addition to describingduties performed, applicants must provide the exact dates of eachperiod of employment (from MM/YY to MM/YY) and the number of hoursworked per week if part time. As qualification determinations cannotbe made when resumes do not include the required information,failure to provide this information may result in disqualification.Applicants are encouraged to use the USAJOBS Resume Builder todevelop their federal resume.****You must submit supporting documentation to verify youreligibility to apply for this vacancy. For most applicants, an SF-50will be required. However, if you are applying as a Veteran,individual with a qualifying disability, or a displaced employee,you will be required to provide other supporting documents asapplicable. *See the Required Documents section for more details.***### Education### Additional information**For some advertisements, the Food & Drug Administration receiveshundreds, even thousands, of applications from job-seekers. Becauseof this high level of interest in positions with the FDA, the agencyreserves the option of setting an application number limit.**When an application limit is set, USAJOBS will close the vacancy at11:59 pm Eastern Time on either:**(A)** the day the limit is reached, ***-OR-*****(B)** the pre-defined closing date of 05/28/2019, whichever comesfirst.If the limit is reached before 11:59 pm ET, all applications inexcess of the limit will continue to be accepted until 11:59 pmET.**The application limit for this advertisement, if applicable,is:***For more information about announcement closing, see:***ADDITIONAL CONDITIONS OF EMPLOYMENT:**- **Pre-employment physical required:** No.- **Drug testing required:** No.- **License required:** No.- **Mobility agreement required:** No.- **Immunization required:** No.- **Bargaining Unit Position:** Yes.- **Incentives may be authorized; however, this is contingent uponfunds availability.**- **If you are serving, or have served in the last 5 years (from05/28/2019) as an Executive Branch political, Schedule C, orNon-career SES appointee, HHS/FDA may be required to obtainapproval by the Office of Personnel Management (OPM) prior tobeginning employment.** You can find out if you have held one ofthese appointment types by looking at your Standard Form 50s inyour Electronic Official Personnel Folder (eOPF), in Section 5where the legal authorities are listed. If you have served orare 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 inthe assessment and certify your responses to the questionnaire.Political Appointees FAQ - OPM- **Veterans Preference:** If you plan to apply based on VeteransPreference, please pay careful attention to the "RequiredDocuments" section for more information about what to provide inyour application. USAJOBS Veterans Site.- **Schedule A:** If you plan to apply under Schedule A based on adisability, please pay careful attention to the "RequiredDocuments" section for more information about what to provide inyour application. USAJOBS Individuals with Disabilities Site.- **Career Transition Programs:** If you are a displaced Federalemployee and plan to apply under CTAP or ICTAP, please paycareful attention to the "Required Documents" section for moreinformation about what to provide in your application. USAJOBSCareer Transtion SIte.- **Financial disclosure statement, OGE-450, required:** Thisposition will be subject to FDA's prohibited financial interestregulation. If you are hired, you may be required to divest ofcertain financial interests. You are advised to seek additionalinformation on this requirement from the hiring official beforeaccepting any job offers.?***All requirements must be met by the closing date of thisannouncement (05/28/2019); only education and experience gained bythis date will be considered. You must continue to meet allrequirements throughout the entire hiring process.***### How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet thequalifications above.Once the job opportunity announcement closes (at 11:59 pm ET on05/28/2019), a review of your resume and supporting documentationwill be conducted, the information will be compared against yourresponses to the assessment questionnaire to determine youreligibility for Federal employment, and then whether you arequalified for this particular position.If, after reviewing your resume and/or supporting documentation, adetermination is made that you have inflated your responses whencompared to your background information, you may be deemedineligible, or your score may be adjusted to more accurately reflectyour skills and abilities. Additionally, we will review yoursupporting documents and resume to determine if you are in the "Areaof Consideration" for this vacancy. Government-Wide Merit Promotionvacancies may only accept applications from a limited audience, paycareful attention to the "Who May Apply" and the "Hiring Paths"information. ***Please follow all instructions carefully. Errors oromissions may affect your eligibility.*****Basis of Rating:** Merit Promotion Procedures for the Food andDrug Administration (FDA) will be used to rate and rank candidates.The category assignment is a measure of the degree in which yourbackground matches the competencies required for this position.Qualified candidates will be ranked into one of two categories:*Best Qualified or Qualified.***Your qualifications will be evaluated on the followingcompetencies (knowledge, skills, abilities and othercharacteristics). You need not respond to the KSA's separately, butyour resume should contain sufficient information to demonstratepossession of these competencies.**1. Technical Competence- Regulatory Counsel.2. Planning and Evaluating.3. Written Communication.4. Oral Communication.***To preview the application questionnaire, click the linkbelow.***### Background checks and security clearance##### Security clearanceQ Access Authorization##### Drug test requiredNo##### Position sensitivity and riskNon-sensitive (NS)/Low Risk##### Trust determination processSuitability/Fitness- Required Documents------------------**These documents will be required for ALL applicants:**- Resume*If you need instructions or assistance with submittingdocumentation, please see the Applicant Help Site - Documentspage.***These documents may be required for some applicants:**- Cover Letter- DD-214- OF-306- Personnel Orders, Schedule A Letter, ICTAP, CTAP Letter- VA Letter or other Veteran-supporting documents- Resume- SF-15- SF-50- Transcript*Documents in this list are being accepted from all applicants, butmay be required for some. If you are unsure what documents mightapply to you, please review the USAJOBS FAQ article: "What types ofdocuments might I need to provide?" or contact the FDA ApplicantHelp Desk.***RESUME REQUIREMENTS:**The federal government has very specific resume requirements. If youhave not written a federal resume before, you may want to watch this**Resume Writing Tutorial** video on the USAJOBS YouTube channel, orread through a helpful **Resume Writing FAQ** on the USAJOBS HelpSite to learn what details you should, and should not, include inyour resume. ***A CV (curriculum vitae) may not contain enoughinformation to meet these resume requirements.***At a minimum your resume should list the position title, employer,start and end dates (including month and year), salary (or grade andstep), hours worked per week, and a list of duties performed oraccomplishments, for EACH position listed.**CURRENT & FORMER FEDERAL EMPLOYEES:**You will need to submit a copy of your most recent SF-50 (StandardForm 50 - Notice of Personnel Action) to verify your eligibilitystatus.Your SF-50 must show the following information:1. Full position title;2. Appointment type;3. Occupational series;4. Pay plan, series, grade, and step;5. Tenure code; and6. Service Computation Date (SCD).If your most recent SF-50 is from an annual pay adjustment, pleaseensure it contains the information listed above. If it does not,then you should also include your most recent SF-50 that does showyour last promotion, execution of appointment, or grade / stepincrease.*Learn more about the SF-50 on the USAJOBS SF-50 Help Page.***VETERANS PREFERENCE:***You must submit a DD-214 form (Certificate of Release or Discharge)that has the dates of service and discharge status.*- **Active Duty Members:** *To claim status Under the VOW(Veterans Opportunity to Work) to hire Heroes Act of 2011,submit written documentation from the armed forces thatcertifies the service member is expected to be discharged orreleased from active duty service in the armed forces underhonorable conditions not later than 120 days after the date thecertification is submitted with your application package.*- **Parents of Deceased or Disabled Veterans:** *To claim statusunder Gold Star Fathers Act of 2015, you must submit a copy ofthe deceased or disabled veterans' DD Form 214, Certificate ofRelease or Discharge from the armed forces that has the dates ofservice and discharge status AND the SF-15, Application for10-point Veterans' Preference. Please follow the instructions inthe SF-15 on required documentation to be submitted.*- **Widow or Widower**: *To claim preference, you must submit acopy of the deceased or disabled veterans' DD Form 214,Certificate of Release or Discharge from the armed forces thathas the dates of service and discharge status AND the SF-15,Application for 10-point Veterans' Preference. Please follow theinstructions in the SF-15 on required documentation to besubmitted.*- **Spouse of a Living Veteran:** *To claim preference, you mustsubmit a copy of the veterans' DD Form 214, Certificate ofRelease or Discharge from the armed forces that has the dates ofservice and discharge status AND the SF-15, Application for10-point Veterans' Preference, and Documentation of Veteran'sInability to Work Because of a Service-Connected Disability.Please follow the instructions in the SF-15 on requireddocumentation to be submitted.*- See the Feds Hire Vets site for detailed information aboutdocumentation requirements.- USAJOBS also maintains a help page for Veterans.**Individuals with Disabilities (Schedule A):**Individuals with intellectual disabilities, severe physicaldisabilities, or psychiatric disabilities, may apply for appointmentthrough the Schedule A hiring authority. Certified verification of adisability from a licensed medical professional; a licensedvocational rehabilitation specialist; or any Federal, state, orDistrict of Columbia agency or U.S. territory that issues orprovides disability benefits will be required. *Learn more on theUSAJOBS Individuals with Disabilities Site.***Displaced Federal employees who qualify for CTAP/ICTAP:**If you are a former Federal employee who was displaced due to aReduction-in-Force (RIF) or surplused by some other means, pleasesubmit a copy of the separation letter or RIF notice from youragency. To be selected under I/CTAP, you must still be foundwell-qualified for this position. *Learn more on the USAJOBS CareerTransition Assistance Site.*#### If you are relying on your education to meet qualification requirements:Education must be accredited by an accrediting institutionrecognized by the U.S. Department of Education in order for it to becredited towards qualifications. Therefore, provide only theattendance and/or degrees from schools accredited by accreditinginstitutions recognized by the U.S. Department of Education.Failure to provide all of the required information as stated in thisvacancy announcement may result in an ineligible rating or mayaffect the overall rating.- Benefits--------A career with the U.S. Government provides employees with acomprehensive benefits package. As a federal employee, you and yourfamily will have access to a range of benefits that are designed tomake your federal career very rewarding. Learn more about federalbenefits.Eligibility for benefits depends on the type of position you holdand whether your position is full-time, part-time, or intermittent.Contact the hiring agency for more information on the specificbenefits offered.- How to Apply------------To apply for positions with the Food & Drug Administration, you musthave a USAJOBS Login.GOV account, and be signed in to that account,before you click "Apply Online". See the USAJOBS Help Site article"How does the application process work?" for more on this process.Additionally, you must provide a resume and any required supportingdocumentation listed on the announcement, and you must complete allassessment questionnaires BEFORE 11:59 pm Eastern Time on theclosing date of this announcement, 05/28/2019 We recommend that youstart the application process early enough that you can complete andsubmit your application before this deadline.**Please note that you cannot submit documentation or make changesto your application after the close date.***If you would like to learn how to use USAJOBS including: accessingand managing your account, adding saved documents, building aresume, or starting an application; we recommend you visit theUSAJOBS How To site, and read up on any topic that you need helpwith. This site is located at:, if you need technical assistance with USAJOBS (such asaccount issues) please visit the main USAJOBS Help site at: FDA's Applicant Help Desk is not ableto support USAJOBS-related issues.***The Food & Drug Administration uses a system called ApplicationManager (USA Staffing) to post jobs and accept applications. If youare not familiar with Application Manager or encounter anydifficulty with the site, we recommend that you review the ApplicantHELP Site at: Thishelp site contains step-by-step instructions for completing theapplication process, submitting documentation, and completingquestionnaires, and should be very helpful to you!**You are encouraged to apply online. Applying online will allow youto review and track the status of your application. The FDA willprovide reasonable accommodation to applicants with disabilities whoare not able to apply online. If you need a reasonable accommodationfor any part of the application process, please contact theApplicant Help Desk. Decisions on granting a reasonableaccommodation will be made on a case-by-case basis.If after reviewing the USAJOBS and Application Manager help sites,you're not able to find the answer to your question or concern, orif you wish to request a reasonable accommodation, please contactthe **FDA Applicant Help Desk** at **888-478-4340**, or e-mail****. The Applicant Help Desk is staffedbetween the hours of 7am and 6pm Eastern Time, Monday throughFriday, except for government holidays. *If you contact theApplicant Help Desk, please provide the following VacancyIdentification Number (VIN) 10484701 so that we may assist youfaster.*### Agency contact information### FDA Applicant Help Desk##### Phone888-478-4340##### AddressCenter for Drug Evaluation and Research10903 New Hampshire AveSilver Spring, MD 20993USLearn more about this agency### Next stepsOnce your application is submitted you will receive anacknowledgement email that your submission was successful. The mosthighly qualified candidates will be referred to the hiring managerfor further consideration and possible interview. We strive to makeselections within 45 days of the closing date of thisannouncement.**You will receive application status updates by email and onUSAJOBS as the process unfolds.***How to check your application status via* *USAJOBS and understandwhat each status means.How does the Hiring Process Work?*- Fair & Transparent------------------The Federal hiring process is setup to be fair and transparent.Please read the following guidance.### Equal Employment Opportunity PolicyThe United States Government does not discriminate in employment onthe basis of race, color, religion, sex (including pregnancy andgender identity), national origin, political affiliation, sexualorientation, marital status, disability, genetic information, age,membership in an employee organization, retaliation, parentalstatus, military service, or other non-merit factor.- Equal Employment Opportunity (EEO) for federal employees & jobapplicants### Reasonable Accommodation PolicyFederal agencies must provide reasonable accommodation to applicantswith disabilities where appropriate. Applicants requiring reasonableaccommodation for any part of the application process should followthe instructions in the job opportunity announcement. For any partof the remaining hiring process, applicants should contact thehiring agency directly. Determinations on requests for reasonableaccommodation will be made on a case-by-case basis.A reasonable accommodation is any change to a job, the workenvironment, or the way things are usually done that enables anindividual with a disability to apply for a job, perform job dutiesor receive equal access to job benefits.Under the Rehabilitation Act of 1973, federal agencies must providereasonable accommodations when:- An applicant with a disability needs an accommodation to have anequal opportunity to apply for a job.- An employee with a disability needs an accommodation to performthe essential job duties or to gain access to the workplace.- An employee with a disability needs an accommodation to receiveequal access to benefits, such as details, training, andoffice-sponsored events.You can request a reasonable accommodation at any time during theapplication or hiring process or while on the job. Requests areconsidered on a case-by-case basis.Learn more about disability employment and reasonable accommodationsor how to contact an agency.#### Legal and regulatory guidance- Financial suitability- Social security number request- Privacy Act- Signature and false statements- Selective Service- New employee probationary periodThis job originated on For the full announcement and toapply, visit Only resumessubmitted according to the instructions on the job announcement listedat will be considered.

Keywords: Food and Drug Administration, Silver Spring , Regulatory Counsel, Other , Silver Spring, Maryland

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