Regulatory Affairs Specialist | Bentley Labs
About The Position
The Regulatory Affairs Specialist supports the development, testing, documentation, labeling, and commercialization of cosmetic, personal care, and over-the-counter (OTC) products. Reporting to the Regulatory Affairs Manager, the role coordinates regulatory documentation, ingredient and formula reviews, labeling support, product testing activities, and customer regulatory requests. The specialist ensures records are accurate, compliant, and maintained to support regulatory and business requirements. The role is based in Edison, New Jersey, and involves work in office, laboratory, and manufacturing environments. The position works with R&D, Quality, Sales, Operations, customers, suppliers, and third-party laboratories.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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 needed.
- Support customer questionnaires, technical requests, and documentation packages.
- Review formulas against regulatory requirements, ingredient restrictions, and customer specifications.
- Support claims substantiation and prepare 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.
- Coordinate third-party testing, 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
