Regulatory Specialist in New Jersey

Reports to: Manager of Regulatory Affairs

Responsibilities:

• Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits.
• With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF).
• Generate and Review of Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheet, technical documents, RM composition breakdown, as may be required for local and international submissions.
• Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Heavy metal statement, Impurity statement, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement.
• Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH Compliant Statements, Global and regional Compliance statements, EU/China-compliant statement, etc....

Job Overview:

The Regulatory Specialist is responsible for ensuring compliance with regulatory requirements in the areas of food safety, labeling, and product registrations. This position requires a thorough understanding of relevant regulations and the ability to interpret and apply them to company policies and practices.

Responsibilities & Duties:

• Monitor and stay current on all relevant regulatory requirements and changes, including FDA, USDA, and international regulations.
• Ensure compliance with labeling regulations and review product labels for accuracy and completeness.
• Work with cross-functional teams to develop and maintain product specifications and ingredient lists.
• Coordinate and monitor product registration and approval processes.
• Prepare and submit regulatory documentation, including ingredient listings, food safety plans, and product registration files.
• Conduct...