The Regulatory and Quality Manager will research, document, maintain and ensure compliance of all production and regulatory requirements. This position will provide feedback and guidance throughout the product lifecycle commencing with the initial process of defining new product quality and regulatory requirements through final approval, market introduction, and existing product changes.
- Creates and/or reviews all new and updated ingredient listing declaration for all products distributed by company. This includes the formula IL and quantitative IL breakdown.
- Reviews all product artwork prior to release for ingredient listing accuracy, part number accuracy, legal address, and product warnings statements
- Prepares, submits and maintains documentation such as artwork, ingredient listing, and finished good specifications to domestic and international authorities for the application and establishment of all Product Registrations. This includes VCRP to US FDA. Maintains and amends these global regulatory filings as needed.
- Responsible for submission of product regulatory review to external consulting firms responsible for raw material international compliance and completion of safety and toxicological assessment
- Maintains all product safety and stability testing documentation executed by R&D in centralized Product Ingredient File (PIF).
- Creates and updates product quality technical manual guidelines and production specifications issued to contract manufacturing suppliers.
- Maintains and creates, as required, product Certificate of Analysis (CofA) and Safety Data Sheets (SDS)
- Documents, investigates, and assigns root cause/corrective action to all company customer complaints and nonconformance reports.
- Provides technical engineering support to R&D, manufacturing and compounding
- Any other responsibilities as assigned
- Minimum 5 years related industry experience, preferably in regulatory affairs
- Detail orientation and strong organizational skills
- Strong spreadsheet and analytical skills, including MS Office expertise in Excel and Word, and Internet proficiency.
- Robust verbal, written, and collaborative communication skills
- Familiarity with Research and Development, Quality Assurance, Manufacturing procedures/protocol, OTC product familiarity
- Bachelors’ Degree in Chemistry or related technical field