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. (as applicable).
• 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, ISO 13485:2003).
• Responsible 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.
• Ability to work on regulatory projects with minimal supervision.
• Responsible for any additional duties or assignments as directed by Manager of Regulatory Affairs.

Requirements

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

Benefits

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