SME II - Cosmetic Chemistry & Product Safety Data

Key Responsibilities: Cosmetic Registration and Product Listing: Apply expertise in product development, scale-up, manufacturing, formulation, and analytical specifications to interpret FDA data as it relates to safety. Use FDA reporting systems to analyze product listing and adverse event information in support of compliance and risk assessment. Ingredient Assessments: Assign functional identifiers to cosmetic ingredients based on their formulation roles, supporting ingredient safety assessments. Tool Identification and Development: Help develop tools that support compliance assignments and risk assessments using facility, listing, and adverse event data. Help link products across multiple FDA systems to support overall safety assessment. Data Reporting: Support timely reporting of product listing, registration, and adverse event findings, and recommend follow-up actions or areas for further collaboration. Guidance and Policy Support: Provide scientific input to guidance and policy documents related to data analyses for cosmetic products and ingredients. Prepare monthly deliverables for the COR documenting work performed and findings.

Required Qualifications: Bachelors or Masters in Chemistry, Pharmaceutical Sciences, or a related field 5+ of relevant professional experience Demonstrated knowledge of cosmetic and/or pharmaceutical formulation, manufacturing, scale-up, and analytical specifications Working knowledge of botanical ingredients and their use in cosmetic products Understanding of ingredient function and classification within formulations Ability to interpret complex safety, listing, and adverse event data Strong technical writing and communication skills Proficiency with Microsoft Office Preferred Qualifications Familiarity with MoCRA (Modernization of Cosmetics Regulation Act of 2022), Cosmetics Direct, or FDA registration and listing programs Experience with FDA adverse event reporting systems or similar pharmacovigilance and safety databases Experience with data tools or methods used for product matching, data integration, or risk prioritization Prior experience supporting FDA or another federal regulatory agencyPPO/HMO Health Plan (includes medical, dental, and vision)