Regulatory Affairs Specialist

Mario Badescu Skin Care is seeking a Regulatory Affairs Specialist to serve as a key regulatory lead across our U.S. and global business. This role is central to ensuring compliance across product development, ingredients and raw materials, packaging, labeling, claims, and international registrations.

This individual will act as a primary regulatory gatekeeper — partnering closely with Product Development, Marketing, Creative, Operations, and International teams to ensure regulatory requirements are integrated from concept through commercialization and throughout the product lifecycle.

• Maintain cosmetic facility registration and product listing submissions in accordance with MOCRA.
• Manage filings and lifecycle updates through FDA Cosmetics Direct.
• Ensure compliance with FDA cosmetic regulations and Fair Packaging & Labeling Act requirements.
• Assess regulatory impact of formulation, manufacturing, and labeling changes.

• Support EU cosmetic compliance, including PIF documentation and CPNP notifications.
• Coordinate with EU Responsible Person as required.
• Prepare and manage Certificates of Free Sale (CFS).
• Support global product registrations and country-specific requirements.

• Review and maintain raw material documentation and regulatory files.
• Partner with R&D and suppliers to obtain required technical documentation.

• Review and approve primary and secondary packaging artwork prior to print.
• Ensure compliance with INCI declarations, allergen disclosures, required warnings, net quantity statements, and international labeling requirements.
• Partner with Creative and Marketing teams to ensure packaging accuracy while preserving brand integrity.

• Review and approve product claims in accordance with FDA cosmetic labeling standards and FTC advertising guidelines.
• Evaluate substantiation and provide clear, risk-based guidance (low / moderate / high) with business impact considerations.
• Support compliance across packaging, digital, retailer PDP, and promotional materials.
• Manage WERCSmart submissions and retailer compliance portals.
• Author and maintain Safety Data Sheets (SDS).
• Support retailer audits and documentation requests.

• Bachelor’s degree in Chemistry, Biology, Regulatory Science, or related scientific discipline required.
• 3–5+ years of cosmetic regulatory experience.
• Strong working knowledge of MOCRA and FDA cosmetic regulations.
• Experience supporting EU compliance, PIF documentation, and international registrations.
• Demonstrated expertise reviewing cosmetic packaging and marketing claims.
• Familiarity with FTC substantiation standards and retailer compliance platforms (WERCSmart preferred).
• Ability to assess and communicate varying levels of regulatory risk and provide practical, commercially aligned solutions.
• Highly organized with strong cross-functional communication skills.