Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate I - Skincare Location: Irvine, CA (Zip Code: 92612) Work Model: Hybrid, 3 days on-site (Local candidates only; relocation candidates will not be considered) Employment Type: 12 months; extensions subject to business need, budget, and performance Position Summary: The Regulatory Affairs Associate I plays a vital supportive role in developing, managing, and executing regulatory strategies and submissions for skincare and over-the-counter (OTC) product portfolios. Working under guidance and structured supervision, this role focuses heavily on regulatory documentation, labeling compliance review, raw material verification, and clear cross-functional alignment. The ideal candidate brings a detail-oriented mindset, sound judgment in navigating ambiguous regulations, and prior regulatory experience-whether gained within cosmetics, OTC products, medical devices, or pharmaceuticals. Comprehensive onboarding and role-specific training (typically a 2-3 month ramp-up period) will be provided by the team. Required Qualifications & Experience: Education & Experience Requirements: Bachelor's Degree (BS) in a scientific field (e.g., Chemistry, Biology, Biochemistry, Life Sciences) with at least 2 years of regulatory affairs or relevant regulatory documentation experience; OR Master's Degree (MS) in a scientific field with at least 1 year of regulatory affairs experience; OR Ph.D. in a scientific discipline (entry-level regulatory affairs candidates welcome). Industry & Functional Background: Hands-on regulatory affairs or documentation compliance experience is required . Background in Cosmetics / Personal Care or OTC (Over-The-Counter) drug monographs is highly preferred. Candidates with strong regulatory experience in Medical Devices (including REACH / RoHS environmental/materials compliance) or Pharmaceuticals are strongly encouraged to apply, as transferable regulatory logic , documentation rigor, and compliance mindset are valued. Core Competencies: Documentation & Proofreading: Proven track record of reviewing documents with high precision and attention to detail. Communication & Collaboration: Excellent written and verbal communication skills to effectively coordinate across departments and summarize regulatory requirements. Adaptability & Critical Thinking: Ability to manage multiple priorities under strict deadlines and exercise sound judgment in "gray areas" where guidelines require interpretation. Preferred Skills (Nice-to-Have) Familiarity with OTC sunscreen/acne monographs or US FDA cosmetic regulations (MoCRA). Prior exposure to artwork/label approval workflows and document management systems. Experience coordinating directly with ingredient/chemical suppliers. Key Responsibilities: Labeling & Packaging Compliance: Review and evaluate product artwork, packaging, and labeling against applicable regulatory guidelines, OTC drug monographs, and cosmetic regulations. Coordinate and communicate planned and approved labeling changes across cross-functional partners (e.g., Operations, Commercial, Medical Affairs). Submissions & Documentation Management: Prepare, format, and track documentation for regulatory submissions, cosmetic notifications/registrations, and health authority correspondence. Ensure complete, accurate, and structured archiving of submissions, official health authority inquiries, internal memos, and audit trails. Ingredient & Formulation Assessments: Generate and review ingredient lists (IL), formulation compliance reviews, and raw material documentation. Assist in generating formal regulatory statements (e.g., Country of Origin, Animal Testing/Cruelty-Free, Allergens, CMR/Nanomaterials, Gluten-Free, BSE/TSE). Partner with raw material suppliers to request, track, and review technical data sheets and safety dossiers. Cross-Functional Advisory & Intelligence: Act as an operational regulatory point of contact for internal teams (R&D/formulation chemists, supply chain, and marketing). Monitor and track federal, state (e.g., California state regulations), and international regulatory developments impacting personal care products. Conduct feasibility reviews of international regulatory requirements to support global market expansion.