Regulatory Affairs Associate - (Quality/Regulatory) - Englewood Lab, Inc

Title: Regulatory Affairs Associate

Reports to: Manager of Regulatory Affairs

Department: Quality/ Regulatory

Responsibilities:

• Assist the Manager of Regulatory Affairs to 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, PFAs, Benzene, DEG/EG statements, etc.
• Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH-Compliant Statements, Certified Organic Ingredients, Global and regional Compliance reports/statements, EU/China-compliant statement, other global jurisdictions, etc. (as applicable).  
• Ensure compliance to all SOPs and other regulatory and trade organizational requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003, COSMOS/ECOCERT, etc).
• Assist the Manager of Regulatory Affairs for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc.), under the direct supervision of the Head of Quality/Regulatory.
• Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training.
• Familiar with SOPs generation process, Specification controls, and Change Control program.
• Familiar with quality management system (QMS) in compliance with 21CFR 210, 211, and 820; and key elements of ISO 13485:2003.
• Maintain familiarity with changing global regulatory requirements.
• Responsible for any additional duties or assignments as directed by Manager of Regulatory Affairs.
• Perform Compliance assessment and generate compliance reports for new formulas undergoing development as needed to support new product launches.
• Generate, review and maintain reports related Cosmos Natural, Cosmos Organic, NOP reports for ingredients and products.
• Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. 

Requirements

• Minimum of Bachelor degree (Life Sciences, Engineering, related profession)
• Experience of drug, cosmetic, medical device regulatory process is a pre-requisite
• Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite
• One year+ years industry or related experience in any combination of cosmetic, medical device, food, or pharma is required.
• Previous regulatory, inspecting, auditing or manufacturing experience - a plus.
• Data analysis skills - a plus.
• Computer literate and effective communication skills

Benefits

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match