Regulatory Program Support Specialist
Employer not yet confirmed · Silver Spring, Maryland, United States · remote
The U.S. Food and Drug Administration (FDA) is seeking a highly motivated and detail-oriented Regulatory Program Support Specialist to provide critical public health and regulatory support to the Food Facility Registration and Complaint Programs. This includes supporting adverse event, product problem, and regulatory misconduct programs. The incumbent will play an integral role in protecting and advancing public health by managing program records, coordinating cross-functional activities, engaging stakeholders, and enabling effective branch operations through data management, system support, and communications.
This is a remote position supporting FDA's mission to ensure the safety, security, and effectiveness of the U.S. food supply. The successful candidate will thrive in a fast-paced, mission-driven environment and demonstrate a commitment to regulatory integrity, public health, and exceptional service delivery.
KEY RESPONSIBILITIES
Public Health & Regulatory Program Support
- 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.
Records Management & Information Governance
- 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.
Stakeholder Outreach & Coordination
- 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.
Branch Operations & Administrative Support
- 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.
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Public Health, Health Sciences, Life Sciences, Business Administration, Information Management, or a closely related field is required.
- Master's degree in a relevant discipline (e.g., Public Health, Health Informatics, Regulatory Affairs) is preferred.
- 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 is a plus.
- Demonstrated ability to enter, maintain, and validate data in electronic information systems or regulatory databases with a high degree of accuracy.
- Analytical & Organizational Skills: Strong ability to analyze program data, identify trends, and prepare clear and concise summary documents, reports, and presentations.
- Collaboration & Adaptability: Proven ability to collaborate effectively across organizational boundaries in a remote work environment, manage competing priorities, and adapt to evolving program requirements.
- Attention to Detail: Exceptional attention to detail in reviewing, entering, and managing regulatory records and program data.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); experience with federal information systems, case management platforms, or regulatory tracking tools is a plus.
PREFERRED QUALIFICATIONS
- Experience working as a project manager is a plus.
- Experience working within a federal government agency or supporting federal contracts is strongly preferred.
- Familiarity with FDA regulations, food safety frameworks, complaint programs, or similar federal public health regulatory programs.
ADDITIONAL INFORMATION
- This position is remote. Candidates must have reliable internet access and a suitable home office environment to fulfill all job duties.
- Candidates should be available during core FDA business hours (Eastern Time) and may occasionally be required to attend virtual meetings or training sessions outside of standard hours.