The Research Regulatory Affairs-Facilities section provides regulatory support for the various cGMP and aspetic processing facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. This section maintains centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aid in development of Quality Systems, and responses to audits.

Duties

As a GS-0601-14 Supervisory Regulatory Affairs Specialist in the Clinical Center, your duties may include but are not limited to the following: Planning and assigning work to be accomplished by subordinates, developing performance standards and evaluating staff performance, and identifying ways to improve production or increase the quality of the work directed. Using regulatory knowledge of the requirements for cGMP and compounding facilities; selects, qualifies and oversees the speciality contracts for cleaning services, pest management, environmental monitoring (to include indentification of specific disinfectents based on the microbial results from monitoring), materials management and vendor qualifications for suppliers. Provides regulatory support for investigators from NIH Institutes performing FDA regulated research including assisting investigators in meeting the Food and Drug Administration requirements for the investigational products and in reviewing and preparing submissions to ensure manufacture or compounding of investigational products meet cGMP or USP standards. Using expertise in FDA and USP regulations and guidance, identifies and designs customized audit and evaluation surveys for each facility, develops protocols to evaluate and validate internal and external research facilities to ensure they meet the regulatory statutes and NIH manufacturing and compounding quality requirements. Preparing reports, briefings, project papers, correspondence and presentations for the Chief and may be requested to make presentations. Providing expertise in FDA and USP regulations, standards and guidance with the design team to ensure that the facility will be in compliance with pertinent regulations and state of the art facility specifications.

Requirements

• 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.
• This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
• At the supervisors discretion, this position may offer work schedule flexibilities: telework, alternative work schedules, and maxiflex.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• This position is designated as a "emergency essential" position. See definition of this designation in the Additional Information Section of this announcement.
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450. See the Additional Information Section of this announcement for more information.

Qualifications

Education Qualification Requirement: In order to qualify for a Supervisory Regulatory Affairs Specialist-GS-601, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to 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 at the time the degree was obtained). Additional Qualification Requirement for GS-14: In addition, in order to qualify for a Supervisory Regulatory Affairs Specialist-GS-601, at the GS-14 level, you must have at least one (1) year of qualifying specialized experience equivalent to at least the GS-13 level in the Federal Government obtained in either the private or public sector performing the following types of tasks:Leading or supervising a subordinate staff responsible for providing regulatory affairs related support for an aseptic processing facility; identifying and developing audits and evaluation surveys for the compliance of aseptic processing facilities; providing regulatory consultation to clinical investigators and clinical staff on aseptic processing facility operations research protocols and procedures; overseeing and reporting on regulatory functions impacting aseptic processing facilities and recommending corrective action plans; interpreting FDA and USP regulations/guidance as relates to aseptic processing facilities; and preparing reports of audit finding and recommendations. 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/12151142

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Dr Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]