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.