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.
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Spectraforce Technologies
Sep 29, 2026