Cosmetics & OTC Regulatory Affairs Specialist

THG; New Jersey; Vor Ort; USD 70.000 - 81.000; Vollzeit

Zusammenfassung

THG in Edison, NJ seeks a Regulatory Affairs Specialist to support development, testing, labeling, and commercialization of cosmetic, personal care, and OTC products. Reporting to the Regulatory Affairs Manager, you will coordinate documentation, ingredient reviews, labeling support, product testing activities, and customer regulatory requests to ensure records are accurate and compliant.

Ideal candidates have about 3 years in regulatory affairs, knowledge of FDA requirements, and experience

Qualifikationen

• Approximately 3 years of experience in Regulatory Affairs, Regulatory Compliance, Product Development Support, or 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.

Aufgaben

• 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.
• 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.
• 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.
• 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.

Kenntnisse

Regulatory affairs

Regulatory compliance

Product development support

FDA requirements

Documentation coordination

Testing coordination

Organization

Microsoft Office

ERP systems

Ausbildung

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related

Jobbeschreibung

THG in Edison, NJ seeks a Regulatory Affairs Specialist to support development, testing, labeling, and commercialization of cosmetic, personal care, and OTC products. Reporting to the Regulatory Affairs Manager, you will coordinate documentation, ingredient reviews, labeling support, product testing activities, and customer regulatory requests to ensure records are accurate and compliant.

Ideal candidates have about 3 years in regulatory affairs, knowledge of FDA requirements, and experience