Regulatory Specialist, Claims Review
About The Position
We are seeking a detail-oriented Regulatory Specialist to support product and marketing claims compliance across dietary supplements, wellness products, and related offerings. This role is responsible for executing structured claims review processes, maintaining substantiation documentation, and ensuring alignment with FDA, FTC, and applicable state-level advertising and labeling requirements. This position plays a critical role in supporting the regulatory function by managing high-volume, day-to-day claims review activities, enabling the broader regulatory and legal teams to focus on strategic initiatives, risk management, and regulatory expansion. The ideal candidate is process-driven, highly organized, and able to operate efficiently within established compliance frameworks while escalating higher-risk issues appropriately.
Requirements
- Strong attention to detail and ability to review content against defined standards
- Ability to follow structured processes and maintain consistency across high-volume reviews
- Foundational understanding (or ability to learn) of FDA/FTC requirements for dietary supplements and advertising
- Ability to identify potential regulatory risk and escalate appropriately
- Strong organizational and documentation management skills
- Effective written and verbal communication skills
- Comfortable working in a fast-paced, high-growth environment with evolving priorities
- Bachelor’s degree or equivalent work experience
- 1–3 years of experience in regulatory, quality, compliance, or related operational roles strongly preferred
Nice To Haves
- Experience in dietary supplements, food, cosmetics, or health/wellness industries is a plus
- Exposure to claims review, labeling, or marketing compliance processes preferred
- Experience working with document management systems or asset review platforms is a plus
Responsibilities
- Claims Review & Substantiation Support Review product, website, and marketing claims against internal guidelines and substantiation standards
- Verify alignment of claims with approved language, supporting evidence, and regulatory requirements
- Identify and flag high-risk or non-compliant claims for escalation to senior regulatory or legal leadership
- Assist in maintaining consistency across product claims, marketing assets, and supporting documentation
- Regulatory Documentation & File Management Organize and maintain claims substantiation files, including scientific references, summaries, and internal approvals
- Maintain documentation related to product specifications, certificates of analysis, and formulation details as they relate to claims support
- Ensure documentation is audit-ready and aligned with internal quality and compliance expectations
- Support internal audits, documentation reviews, and regulatory readiness initiatives
- Cross-Functional Support & Communication Serve as a point of contact for marketing and cross-functional teams on claims-related questions
- Provide approved language and ensure consistency in claim usage across channels
- Respond to internal requests in a timely manner while adhering to established review processes
- Coordinate with regulatory, legal, and product teams to ensure alignment on claims-related decisions
- Tracking, Reporting & Process Adherence Track key metrics including volume of claims reviewed, turnaround time, and escalation rates
- Maintain logs of reviewed assets and associated determinations
- Support continuous improvement of claims review workflows and documentation practices
- Adhere strictly to established SOPs, templates, and regulatory review processes
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
