Job Description

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 Vendors/suppliers for RM documents and follow up on request with vendors.
• Ability to use in-house and 3rd party portal to generate compliance documents, product information packets, Product / Formulary SDS, Toxicology statements, etc, as applicable.
• Review formulas, ingredients, and associated documents for compliance with designated regulatory filings and proposed submissions. Notify heads of quality and R&D (or designee) regarding any discrepancies or deficiencies with filings and items intended for submissions.
• Co-ordinate investigations (audit findings, etc); correspondences to regulatory audits; and registration of products and facility with agencies.
• Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, TGA, Japan, Health Canada, ISO, EU, China CSAR, etc).
• Responsible for facility registrations, renewals, and document submissions to regulatory agencies under the direct supervision of the Head of Quality.
• Assist the Manager during periodic regulatory 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 US 21CFR 210, 211.
• Maintain familiarity with changing global regulatory requirements.
• Assist with CARES Act drug reporting, Product Listing and MoCRA registrations.

Requirements

• Minimum of Bachelor degree (Life Sciences, Engineering, related profession).
• Experience of drug, cosmetic, or medical device regulatory is a pre-requisite.
• Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite.
• Three + 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

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