Regulatory Program Support Specialist

The U.S. Food and Drug Administration (FDA) is hiring a Regulatory Program Support Specialist to support its Food Facility Registration and Complaint Programs. The role manages program records, coordinates stakeholder activities, supports data and systems, and assists with regulatory and public health operations.

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
• Actively support efforts to reduce and manage review backlogs, ensuring timely processing of regulatory submissions and complaints
• Assist in the interpretation and application of applicable FDA regulations, policies, and program guidance documents
• Coordinate and maintain record-keeping systems in support of 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, and other public health and government entities
• Support the completion of records-related regulatory and public health activities through proactive engagement and effective communication with diverse audiences
• Serve as a liaison between program offices and external partners, facilitating the flow of information and supporting collaborative regulatory initiatives
• Support and advise branch operations by performing system testing to verify functionality and data integrity across FDA program systems
• Respond to internal and external inquiries in a timely, accurate, and professional manner, ensuring consistent and high-quality service
• Enter, validate, and maintain program data across regulatory databases and information systems, ensuring data accuracy and completeness
• Prepare professional presentations and develop summary documents, reports, and briefing materials for leadership and stakeholder audiences

Preferred

• Master's degree in a relevant discipline (e.g., Public Health, Health Informatics, Regulatory Affairs)
• 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
• Relevant Master's Degree
• Federal Information Systems
• Case Management Platforms
• Regulatory Tracking Tools
• Project Management
• Federal Agency Experience
• Federal Contract Support
• FDA Regulations
• Food Safety Frameworks
• Complaint Programs
• Federal Public Health Regulations

Benefits

• This is a remote position.

Company

• Mission integrator for emerging technology in critical operations
• Reston, Virginia, USA
• http://www.saic.com/
• Founded in 1969
• 10001+ employees

Qualifications

• Bachelor's degree in Public Health, Health Sciences, Life Sciences, Business Administration, Information Management, or a closely related field is required
• Minimum of three (3) to five (5) 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
• knowledge of federal records management standards
• Demonstrated 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
• Proven ability to collaborate effectively 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
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Knowledge of federal records management standards
• Master's degree in a relevant discipline (e.g., Public Health, Health Informatics, Regulatory Affairs)
• 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
• Minimum of three (3) to five (5) years of experience in regulatory program support, public health, records/information management, or a directly related field.

Required skills

• Data Validation, Document Control, FDA Regulations, Federal Records Management Standards, Food Safety, Information Governance, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Regulatory Compliance, Regulatory Databases, Regulatory Records Management

Preferred skills

• Experience working as a project manager

Experience

• 3-5 years