Full-time
Regulatory Affairs Supervisor - (Regulatory)
Englewood Lab, Inc
totowa, new jersey
Responsibilities
- Assist the Manager during cGMP, Environmental, and Regulatory audits.
- Assist the Manager to create and collate product master files (dossiers), drug master files (DMF).
- Generate and Review of CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, RM Safety Data Sheet, RM technical documents, RM composition breakdown, as may be required for local and international submissions.
- Generate Raw Material Regulatory statement: Origin Statement, Clean List, Sephora, Ulta, Cruelty Free statement, Heavy metal statement, Impurity statement, REACH-Compliant Statements, Global and regional Compliance statements, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement, EU/China-compliant statement, etc. (as applicable).
- Responsible for Gluten free, organic (USDA/ Ecocert) regulatory submission and share updated regulation within team members.
- Manage communication with...