Prequel
We formulate using tried and true dermatological ingredients and elevate them with unique sensorial and tactile experiences. Because we believe that products should not only work but also provide an experience that makes you genuinely love and enjoy using them every day.
Purpose The QA + Regulatory Manager ensures product compliance, product safety, documentation accuracy, and quality system adherence across the product lifecycle. This role manages quality and regulatory integrity while partnering with cross-functional teams to support timely launches with ongoing compliance and calculated risk.
Duties and 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.
Qualifications
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.
Regulatory expertise, accuracy, risk awareness, cross-functional communication.
Status Requirements Full time in office Monday-Friday
Location: West Hollywood, CA
#J-18808-Ljbffr
Purpose The QA + Regulatory Manager ensures product compliance, product safety, documentation accuracy, and quality system adherence across the product lifecycle. This role manages quality and regulatory integrity while partnering with cross-functional teams to support timely launches with ongoing compliance and calculated risk.
Duties and 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.
Qualifications
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.
Regulatory expertise, accuracy, risk awareness, cross-functional communication.
Status Requirements Full time in office Monday-Friday
Location: West Hollywood, CA
#J-18808-Ljbffr