Regulatory Affairs Coordinator
Location: Santa Fe Springs, CA
Department: Regulatory Affairs
Reports To: Regulatory Affairs Manager
Job Type: Full-Time
Job Summary:
The Regulatory Affairs Coordinator will support the Regulatory Affairs team in ensuring compliance with FDA, MOCRA, California GMP, EU, and international cosmetic regulations. This role will assist in the preparation and maintenance of regulatory documentation, product registrations, safety assessments, and audits while collaborating with cross-functional teams, including R&D, Quality, and Production.
Key Responsibilities: Regulatory Compliance & Documentation:
- Assist in the preparation, submission, and maintenance of regulatory documentation, including Safety Data Sheets (SDS), Ingredient Lists (ILs), Product Information Files (PIFs), and Certificates of Analysis (COAs).
- Ensure compliance with MOCRA, FDA, California Prop 65, and international cosmetic regulations (EU, Canada, UK, etc.).
- Maintain regulatory records, including product formulations, labeling compliance, and ingredient traceability.
- Conduct label and claims review to ensure all marketing, packaging, and labeling materials comply with U.S. and international regulations.
- Support compliance with ECOCERT, COSMOS, Vegan, Cruelty-Free, and other sustainability-related certifications.
Regulatory Support & Cross-Functional Collaboration:
- Support the SMETA 4-Pillar audits, ISO 22716 certification, and GMP desk audits by preparing required documentation and assisting with inspections.
- Assist with customer regulatory requests, including QQ statements, vegan, gluten-free, cruelty-free claims, and international registrations.
- Work with R&D and Quality teams to ensure that formulas meet regulatory standards and report any ingredient restrictions or bans..
- Keep up to date with evolving regulations and industry standards and communicate key updates to internal teams.
- Coordinate regulatory responses for customer inquiries and third-party auditors.
Product Registration & Safety Compliance:
- Support international product registrations for global markets.
- Assist in compiling and submitting data for EcoVadis sustainability reporting.
- Maintain ingredient and formula databases to ensure compliance with EU (CPNP), Canada (NNHPD), and other international authorities.
- Ensure proper classification of hazardous materials (DOT, IATA, IMDG, TDG) and provide correct shipper markings.
Qualifications:
- 1-3 years of experience in Regulatory Affairs, preferably in cosmetics or personal care manufacturing.
- Familiarity with MOCRA, FDA, EU Cosmetic Regulations (EC 1223/2009), REACH, and California Prop 65.
- Knowledge of GMP, ISO 22716, and SMETA 4-Pillar audits is a plus.
- Understanding of SDS authoring, transportation classifications (DOT, IATA, IMDG, TDG), and product safety regulations.
- Strong attention to detail, organizational skills, and ability to manage multiple projects simultaneously.
- Proficiency in Google Workspace (Sheets, Docs) and regulatory software is a plus.
- Ability to work cross-functionally with R&D, Quality, and customers on regulatory requirements.
- Excellent written and verbal communication skills.
Job Type: Full-time
Pay: $17.00 - $22.00 per hour
Benefits:
- Health insurance
- Paid time off
Education:
- High school or equivalent (Preferred)
Experience:
- Microsoft Office: 1 year (Preferred)
Work Location: In person
