Regulatory Program Support Specialist

SAIC•Silver Spring, MD

1d•Remote

About The Position

The U.S. Food and Drug Administration (FDA) is seeking a detail-oriented Regulatory Program Support Specialist to support the Food Facility Registration and Complaint Programs, including adverse event reporting, product problem tracking, and regulatory misconduct programs. The role supports FDA’s public health mission through regulatory program assistance, records management, stakeholder coordination, system support, data management, and communications. The position is remote and supports the safety, security, and effectiveness of the U.S. food supply. The specialist helps manage review backlogs and process regulatory submissions and complaints in a timely manner; assists with applying FDA regulations, policies, and guidance; and maintains records and information governance practices in accordance with federal standards and FDA policies. The role coordinates with FDA offices and divisions, consumers, industry representatives, public health organizations, government entities, and external partners. The position also supports branch operations through system testing, inquiry response, data entry and validation, and preparation of presentations, reports, summaries, and briefing materials. Candidates need a bachelor’s degree in a relevant discipline and three to five years of related experience. A relevant master’s degree is preferred. Candidates must have reliable internet and a suitable home office, and 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 or 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 accurately.
Ability to analyze program data, identify trends, and prepare clear and concise summaries, reports, and presentations.
Ability to collaborate across organizational boundaries in a remote work environment, manage competing priorities, and adapt to changing program requirements.
Exceptional attention to detail when 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 in Eastern Time; occasional virtual meetings or training outside standard hours may be required.

Nice To Haves

A 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.
Help 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 supporting 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 internal and external stakeholders, including consumers, industry representatives, public health organizations, and government entities.
Support records-related regulatory and public health activities through proactive engagement and communication with diverse audiences.
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 across FDA program systems.
Respond to internal and external inquiries accurately, professionally, and in a timely manner.
Enter, validate, and maintain program data in regulatory databases and information systems, ensuring accuracy and completeness.
Prepare presentations, summary documents, reports, and briefing materials for leadership and stakeholders.