Regulatory Program Support Specialist

SAIC•Flexwork, AR

1d•Remote

About The Position

The U.S. Food and Drug Administration (FDA) is seeking a highly motivated and detail-oriented Regulatory Program Support Specialist to provide public health and regulatory support to the Food Facility Registration and Complaint Programs, including adverse event reporting, product problem tracking, and regulatory misconduct programs. The role supports FDA’s mission to ensure the safety, security, and effectiveness of the U.S. food supply and contributes to public health through program records management, cross-functional coordination, stakeholder engagement, data management, system support, and communications. This is a remote position. The successful candidate will support efforts to reduce and manage review backlogs, assist with applying FDA regulations and program guidance, maintain regulatory records and information governance practices, coordinate with internal and external stakeholders, and support branch operations. Duties also include system testing, responding to inquiries, maintaining accurate data in regulatory systems, and preparing presentations, reports, summaries, and briefing materials. Candidates must have reliable internet access and a suitable home office environment and should be available during core FDA business hours in Eastern Time. Occasional virtual meetings or training outside standard hours may be required.

Requirements

Bachelor’s degree in Public Health, Health Sciences, Life Sciences, Business Administration, Information Management, or a closely related field.
Three to five years of experience in regulatory program support, public health, records/information management, or a directly related field.
Demonstrated experience managing regulatory records, document control, or compliance-related activities in a government or highly regulated environment.
Proficiency in document control, records management, and information governance practices.
Ability to enter, maintain, and validate data in electronic information systems or regulatory databases with a high degree of accuracy.
Strong ability to analyze program data, identify trends, and prepare clear and concise summary documents, reports, and presentations.
Ability to collaborate across organizational boundaries in a remote work environment, manage competing priorities, and adapt to evolving program requirements.
Exceptional attention to detail in reviewing, entering, and managing regulatory records and program data.
Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
Reliable internet access and a suitable home office environment.
Availability during core FDA business hours (Eastern Time), with occasional virtual meetings or training outside standard hours.

Nice To Haves

Master’s degree in a relevant discipline, such as Public Health, Health Informatics, or Regulatory Affairs.
Knowledge of federal records management standards.
Experience with federal information systems, case management platforms, or regulatory tracking tools.
Experience working as a project manager.
Experience working within a federal government agency or supporting federal contracts.
Familiarity with FDA regulations, food safety frameworks, complaint programs, or similar federal public health regulatory programs.

Responsibilities

Provide public health and regulatory support to the Food Facility Registration and Complaint Programs, including adverse event reporting, product problem tracking, and regulatory misconduct programs.
Support efforts to reduce and manage review backlogs and ensure timely processing of regulatory submissions and complaints.
Assist in interpreting and applying applicable FDA regulations, policies, and program guidance documents.
Coordinate and maintain record-keeping systems for regulatory program activities.
Direct document control processes, manage archives, and administer information governance practices in accordance with federal standards and FDA policies.
Collaborate across FDA offices and divisions to ensure information is accurately captured, accessible, and maintained in compliance with applicable frameworks.
Conduct outreach and coordinate with consumers, industry representatives, and other public health and government entities.
Support records-related regulatory and public health activities through proactive engagement and effective communication.
Serve as a liaison between program offices and external partners, facilitating information flow and collaborative regulatory initiatives.
Support and advise branch operations, including testing systems to verify functionality and data integrity.
Respond to internal and external inquiries in a timely, accurate, and professional manner.
Enter, validate, and maintain program data across regulatory databases and information systems.
Prepare professional presentations, summary documents, reports, and briefing materials for leadership and stakeholder audiences.