Job Description

Job Summary:

The Regulatory Claims Substantiation Specialist is responsible for evaluating, developing, and maintaining substantiation for marketing and product claims across all media and platforms. This role ensures that all claims made in advertising, packaging, digital content, and promotional materials are accurate, evidence-based, and compliant with applicable regulatory requirements and industry standards. The ideal candidate has a strong background in regulatory compliance, scientific analysis, and cross-functional collaboration, particularly in industries such as consumer products, cosmetics, supplements, or food and beverage.

General Duties & Responsibilities:

• Review marketing, advertising, and product claims to ensure they are truthful, not misleading, and supported by appropriate scientific or technical evidence.
• Work cross-functionally with Legal, Marketing, Product Development, Quality teams to evaluate and substantiate claims during product development and post-launch.
• Develop and maintain a claims substantiation database or dossier system, including scientific literature, clinical studies, internal reports, and third-party validations.
• Interpret and apply regulatory guidelines and standards (e.g., FDA, FTC etc.) to support US claim compliance.
• Monitor changes in the regulatory landscape and assess their impact on current and future product claims.
• Conduct gap analyses of current claims and provide risk assessments and recommendations.
• Liaise with external consultants, legal counsel, or third-party testing agencies as needed.
• Support internal training efforts to educate teams on compliant claims development and substantiation standards.

Attributes:

• Strong analytical and critical thinking skills with attention to detail
• Exceptional written and verbal communication
• Ability to translate scientific or technical data into clear, consumer-friendly language
• Proactive, self-motivated, and adaptable in a fast-paced, cross-functional environment
• High ethical standards and a strong sense of accountability

Knowledge & Skills Preferred:

• Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Nutrition, Chemistry, or a related scientific field
• 3+ years of experience in Regulatory Affairs or Compliance roles with a focus on claims substantiation
• Familiarity with regulatory frameworks governing advertising and labeling (e.g., FDA, FTC, etc.)
• Experience evaluating clinical studies, scientific literature, or technical data for claim support
• Knowledge of substantiation standards for different types of claims (e.g., structure-function, nutrient content, marketing, sustainability, etc.)
• Understanding of risk management principles as applied to marketing communications
• Proficiency with digital tools (e.g., Microsoft Office, document management systems, regulatory databases)

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