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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Non-profit Organizations and Primary and Secondary Education
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