Regulatory Assistant

Regulatory Assistant

The Regulatory Assistant supports the company's regulatory compliance activities for skincare, cosmetic, personal care, and related consumer products sold in the United States and international markets. This position maintains regulatory documentation, assists with product and packaging reviews, tracks regulatory requirements and deadlines, and coordinates information among internal departments, headquarters, manufacturers, suppliers, laboratories, consultants, and business partners.

The Regulatory Assistant must be highly organized, detail-oriented, and able to manage multiple products, documents, and deadlines. The position identifies and escalates potential compliance concerns but does not independently approve formulas, labels, claims, product registrations, or regulatory strategy unless specifically authorized.

Essential duties and responsibilities include the following. Other duties may be assigned.

Regulatory Documentation and Records

• Maintain accurate and organized regulatory files for products, ingredients, formulas, packaging, testing, claims, safety information, and supporting documentation.
• Collect, review, organize, and track product specifications, ingredient lists, certificates of analysis, safety data sheets, test reports, manufacturing information, and supplier documentation.
• Maintain regulatory databases, product trackers, registration records, standard operating procedures, and departmental reference materials.
• Monitor document requests, formula changes, artwork revisions, registration status, renewals, corrective actions, and regulatory deadlines.

Product, Labeling, and Claims Support

• Assist with reviews of product labels, cartons, inserts, website content, marketing materials, and product claims for consistency with applicable requirements and approved product information.
• Identify missing, inconsistent, or potentially noncompliant information and promptly escalate concerns to management.
• Support regulatory assessments for new products, reformulations, packaging changes, product launches, and product discontinuations.
• Coordinate regulatory feedback with Marketing, Sales, Product Development, Quality, Operations, Customer Care, E-Commerce, and other departments.

Registrations and Regulatory Compliance

• Assist with U.S. cosmetic facility registration, product listing, recordkeeping, adverse-event documentation, and other activities required under applicable FDA requirements and company procedures.
• Support product registrations, notifications, renewals, retailer compliance requests, and market-entry documentation in the United States and international markets.
• Assist with documentation required for products distributed in Canada, the United Kingdom, the European Union, and other markets.
• Monitor regulatory developments affecting cosmetics, skincare, personal care products, ingredients, labeling, packaging, claims, product safety, and environmental requirements.

Cross-Functional and External Coordination

• Communicate with headquarters, manufacturers, laboratories, consultants, distributors, suppliers, and business partners to obtain required regulatory information.
• Assist with responses to regulatory questions from customers, retailers, business partners, and internal departments.
• Support investigations and documentation involving product complaints, adverse events, labeling issues, or other potential compliance concerns.
• Prepare reports, summaries, presentations, and supporting materials for management and maintain the confidentiality of product, formula, supplier, and business information.

Qualifications & Experience

• Associate degree or bachelor's degree in regulatory affairs, chemistry, biology, cosmetic science, pharmaceutical science, business administration, or a…