Regulatory Affairs Specialist | Bentley Labs

The Regulatory Affairs Specialist supports the development, testing, documentation, labeling, and commercialization of cosmetic, personal care, and OTC products. Reporting to the Regulatory Affairs Manager, this role is responsible for coordinating regulatory documentation, ingredient and formula reviews, labeling support, product testing activities, and customer regulatory requests. The successful candidate will ensure records are accurate, compliant, and maintained to support regulatory and business requirements.

• Prepare, maintain, and organize regulatory documentation, including ingredient lists, specifications, product dossiers, certificates, and technical records.
• Maintain accurate ingredient, raw material, and product data within regulatory and ERP systems.
• Request, track, and review supplier documentation, escalating missing or incomplete information as required.
• Support customer questionnaires, technical requests, and documentation packages.

Formula, Claims & Labeling Support

• Review formulas against regulatory requirements, ingredient restrictions, and customer specifications.
• Support claims substantiation and preparation of regulatory declarations and customer attestations.
• Review ingredient listings, labels, and packaging content for compliance and accuracy.
• Assist with U.S. FDA cosmetic and OTC requirements and applicable international regulations.

Product Testing & Laboratory Coordination

• Coordinate third-party testing activities, including sample submissions, quotations, timelines, and reporting.
• Track stability, preservative efficacy, RIPT, and other testing programs.
• Compile testing documentation and follow up on outstanding results.
• Support preparation of customer testing packages and product dossiers.

Compliance & Cross-Functional Collaboration

• Respond to routine regulatory and customer inquiries, escalating complex matters when required.
• Partner with R&D, Quality, Operations, suppliers, and external laboratories to resolve regulatory and documentation issues.
• Support regulatory inspections, customer audits, and quality audits through document retrieval and follow-up actions.
• Maintain trackers, meet regulatory deadlines, and identify opportunities to improve processes and record accuracy.

• Approximately 3 years of experience in Regulatory Affairs, Regulatory Compliance, Product Development Support, or a related function within cosmetics, personal care, OTC, or another regulated industry.
• Working knowledge of FDA requirements, product labeling, ingredient documentation, and regulatory compliance practices.
• Experience preparing regulatory documentation, coordinating testing activities, and supporting technical or customer requests.
• Strong organization, attention to detail, communication, and project management skills.
• Proficiency in Microsoft Office and the ability to learn regulatory databases and ERP systems.

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Experience with INCI nomenclature, global cosmetic regulations, and product information files.
• Exposure to OTC testing, stability studies, micro challenge testing, RIPT, and laboratory coordination.
• Familiarity with Ithos or similar regulatory management systems.