Senior Manager, Claims Substantiation

We are looking for a Senior Manager, Claims Substantiation to lead the development, review, substantiation, and governance of all product claims across the company's beauty, personal care, wellness, and cosmetic portfolios. This role serves as the subject matter expert for claims compliance and substantiation, ensuring all marketing claims are truthful, adequately supported, and compliant with applicable regulations.

The Senior Manager will work closely with Product Development, R&D, Marketing, Legal, and testing partners to establish robust claims strategies to support innovation while reducing regulatory and litigation risks.

This role is based in our Manhattan office and requires 3 days per week on-site.

Key Responsibilities

Claims Strategy & Governance

Engage with Product Development early in the process in developing impactful and compelling claims strategies that differentiate products while maintaining compliance with regulatory requirements.
Lead the claims review and approval process for new product launches, line extensions, and reformulations.
Evaluate proposed marketing, e-commerce, social media, packaging, and advertising claims for risk and substantiation needs.
Establish and maintain company claims governance policies, procedures, and workflows.
Update and maintain centralized claims library and substantiation database.

Key Responsibilities

Claims Strategy & Governance

Engage with Product Development early in the process in developing impactful and compelling claims strategies that differentiate products while maintaining compliance with regulatory requirements.
Lead the claims review and approval process for new product launches, line extensions, and reformulations.
Evaluate proposed marketing, e-commerce, social media, packaging, and advertising claims for risk and substantiation needs.
Establish and maintain company claims governance policies, procedures, and workflows.
Update and maintain centralized claims library and substantiation database.

Claims Substantiation
Determine appropriate substantiation requirements for product performance, sensory, consumer perception, and ingredient-related claims.
Develop testing plans utilizing clinical, consumer, instrumental, laboratory, and expert review methodologies.
Review statistical analyses and technical reports to ensure claims are adequately supported.
Prepare claims dossiers and substantiation files for regulatory and legal defense.
Partner with external laboratories, dermatologists, toxicologists, and scientific experts on claims validation
Lead continuous improvement initiatives to streamline claims review processes.

Regulatory Compliance

Ensure claims compliance with FDA, FTC, NDA and applicable global cosmetic regulations.
Assess claims for potential cosmetic, drug, medical device, or food classification implications.
Monitor warning letters, litigation trends, competitor activity, and emerging regulatory requirements related to claims.
Provide regulatory risk assessments and recommendations to business stakeholders.

Cross-Functional Collaboration

Partner with Product Development, R&D and Marketing teams to create compelling, compliant messaging.
Collaborate with Product Development to identify substantiation opportunities early in the innovation process.
Work with Legal on claim challenges, advertising reviews, and risk mitigation strategies.
Support retailer review submissions and customer-specific compliance requirements.

Qualifications

Bachelor’s degree in chemistry, Biology, Cosmetic Science, or related field.
10+ years of experience in cosmetic, personal care, OTC, or CPG industries.
8+ years of direct experience in product claims substantiation and regulatory compliance.
Demonstrated experience reviewing advertising, packaging, and digital marketing claims.
Experience managing external testing laboratories and substantiation studies.
Prior leadership experience managing cross-functional projects.

Required Knowledge & Skills

FDA, FTC, NDA Cosmetic Regulations related to Advertising claims
Cosmetic vs. Drug Claim Distinction
Clinical, Technical and Consumer Testing Methodologies
Statistical Interpretation of Test Results
Experience with claims dossier development and documentation management.
Ability to communicate complex scientific and regulatory concepts to non-technical audiences.
Strong project management and stakeholder management skills.
Excellent written and verbal communication skills.