Regulatory Affairs Specialist- (Quality, Regulatory)

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....