Regulatory Affairs Specialist

Employer
USAJobs
Location
Frederick, Maryland
Posted
Nov 28, 2022
Closes
Dec 06, 2022
Function
Administrative
Hours
Full Time
Duties

As a Regulatory Affairs Specialist, your typical work assignments may include:
  • Drafting, organizing, submitting, and tracking all clinical trial lifecycle requirements for investigators.
  • Managing a portfolio of clinical trials.
  • Preparing and submitting all regulatory submissions, including initial protocols, amendments, continuing reviews, etc., and responses to questions/stipulations.
  • Preparing and submitting all submissions to ancillary support and oversight committees (e.g., scientific review, radiation safety, biosafety, data/safety monitoring).
  • Ensuring that all regulatory submissions are in compliance with HHS, NIH, and NCI regulations, guidelines, and policies.
  • Providing documents and information, as required, to meet sponsor submission and ongoing reporting requirements to the Food and Drug Administration (FDA) (e.g., Investigational New Drug [IND] and Investigational Device Exemption [IDE] applications).
  • Serving as a liaison between the OCD and regulatory agencies and research sponsors (i.e., IRB, NCI CTEP, pharmaceutical companies, Contract Research Organizations (CROs), etc.)
  • Providing advice and assistance to clinical investigators to assure compliance with regulations and reporting.


Requirements

Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • Position has an education requirement. Please submit transcripts.


Qualifications

Basic Qualifications

In order to qualify for a Regulatory Affairs Specialist, GS-0601, position you must have successfully completed a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (https://ope.ed.gov/accreditation) at the time the degree was obtained).

Additional Qualifications

GS-12: In addition, to qualify for a Regulatory Affairs Specialist position at the GS-12 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing regulatory guidance, review, and assistance to clinical investigators and other clinical regulatory staff; reviewing clinical protocols for regulatory compliance and internal consistency; ensuring Investigational New Drug (IND) and Investigational Device Exemption (IDE) products are in compliance with regulations and industry best practices; supporting maintenance of safety trackers and databases; and providing professional and technical assistance to staff and research study teams.

GS-13: In addition, to qualify for a Regulatory Affairs Specialist position at the GS-13 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing expert regulatory guidance to investigators, team members, and pharmaceutical partners, including technical expertise, on the development of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and requests; preparing meeting requests and briefing documents and advising investigators on questions and format for meetings; providing writing guidance for internal inspections; evaluating safety report cases for validity and consistency; and developing and maintaining liaison for site performance and compliance issues.

You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.

Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11705245

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education .

Additional information

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .
  • Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine. Employees providing healthcare or services in support of healthcare (Healthcare Workforce) may be required to receive a COVID-19 vaccine because they are expected to perform duties that put them in contact or potential contact with patients. We may request COVID-19 vaccination, and other vaccination documentation from Healthcare Workforce personnel at any point during the onboarding process or at any time during your employment with NIH.
  • This position is designated as a " non-emergency/teleworker " position and the selected candidate will be considered a " non-emergency/teleworker " employee. In the event of a closure, you must be available to telework or request leave.
  • At the supervisor's discretion, this position may offer work schedule flexibilities : telework.
  • A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
  • A one-year probationary period may be required upon selection/placement.
  • PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration
  • We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
  • The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
  • The NIH maintains a tobacco free work environment and campus.
  • Must be able to perform the essential duties of the position, with or without reasonable accommodation.
  • Visit our Applicant FAQs page for helpful information on the application process.
  • Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.