Prequel ยท 1 day ago
QA and Regulatory Manager
West Hollywood, CA
Full-time
Onsite
Mid, Senior Level
4+ years expPrequel is a company focused on creating dermatological products that provide unique sensorial experiences. The QA + Regulatory Manager ensures product compliance and safety while managing quality systems and collaborating with cross-functional teams to support product launches.
Retail
Hiring Manager
Dr. Dena H.
Responsibilities
Document formula approvals internally and send official approvals with appropriate test plans, to partnering contract manufacturers
Manage and coordinate samples, protocols, and quotes for all product testing
Work with regulatory consultants to acquire all formula, raw material and compliance documentation for approved formulas and record internally
Work with regulatory consultants on final FDA OTC copy and testing requirements as needed
Work with regulatory consultants to finalize ILs for artwork
Review Master Copy Worksheets and routing artwork files for accuracy and compliance, as needed
Work with regulatory to register products with MoCRA, WERCs, and EU/UK/CAN, as needed
Maintain product dossiers/PIF folders. Ensure product information is always up-to-date and accurate to prepare for transaction
Review test results for new products and manage timelines for testing and final reports
Address any stability and/or compatibility issues with appropriate CM for formula adjustments and additional monitoring
Communicate formula development testing status and any product issues to the cross-functional teams when needed to adjust timing for samples, components, overall launch information
Work with both Contract Manufacturers and Product Management Teams on pilot and production batch timing and on-site visits. Travel required
Review batch samples, finished goods/BMEs, and COAs for all pilot batches/line trials and production
Maintain digital storage of all COAs and production samples
Manage overall quality process and change control for all products
Support ongoing formula and packaging revisions, including size extensions, to ensure products meet all regulatory and testing requirements
Support audits, vendor qualifications, and GMP compliance
Collaborate with Product Development to evaluate any formula changes and claims feasibility/bridging, as needed
Monitor regulatory trends and provide guidance to internal teams
Manage follow-ups and resolution for all quality issues and CAPAs
Qualification
Required
4-5 years of experience in quality assurance within cosmetics or personal care
Experience in regulatory affairs and/or working with a regulatory team
Experience with standard product safety and clinical testing for non-OTC and OTC cosmetic products
Strong understanding of global regulatory frameworks
Excellent documentation, compliance, and organizational skills
Company
Prequel
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase