Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU)
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| Job Type | Temporary / Contract |
| Location | United Kingdom |
| Area | EMEA (other), Rest of World |
| Sector | Clinical Research |
| Salary | £0 per year |
| Currency | gbp |
| Start Date | ASAP |
| Advertiser | remoteapi |
| Job Ref | 1477 |
| Job Views | 410 |
- Description
Freelance Director of Regulatory Affairs - Cosmetics (U.S. & EU)
Location: Remote
Contract Type: Freelance / Consultant
Reports To: EVP Regulatory Affairs
Position Overview:
We are seeking an experienced and strategic Regulatory Affairs Director with expertise in cosmetic product regulations across the United States and European Union. This freelance role is ideal for a professional who can lead compliance efforts, manage regulatory submissions, and guide product development in line with evolving global legislation.
Key Responsibilities:
Regulatory Strategy & Compliance
- Develop and implement regulatory strategies aligned with:
- U.S. regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Modernization of Cosmetics Regulation Act (MoCRA).
- EU regulations, including Regulation (EC) No 1223/2009 and its amendments such as Regulation (EU) 2025/877.
- Ensure product safety, labeling, and marketing materials comply with:
- FDA requirements for facility registration, product listing, adverse event reporting, and safety substantiation.
- EU mandates on ingredient bans, nanomaterial restrictions, and CMR substance prohibitions.
Product Development Support
- Advise on regulatory implications of formulations and claims.
- Review technical documentation, ingredient safety data, and labeling for compliance.
Submission & Communication
- Manage:
- FDA Voluntary Cosmetic Registration Program (VCRP) and Cosmetic Product Ingredient Statements (CPIS).
- EU Product Information Files (PIFs)
- Liaise with FDA, EFSA, European Commission, and national competent authorities.
Risk Management & Documentation
- Conduct regulatory risk assessments and develop mitigation strategies.
- Maintain comprehensive regulatory documentation and ensure audit readiness.
Qualifications:
- 10+ years' experience in regulatory affairs, with a focus on cosmetic products.
- Proven success navigating FDA, MoCRA, and EU Regulation 1223/2009 compliance.
- Strong understanding of:
- Good Manufacturing Practices (GMP) and labeling laws in both regions.
- EU Annex II (prohibited substances), Annex III (restricted substances), and Annex V (preservatives).
- Excellent communication, analytical, and project management skills.
- Ability to work independently and manage multiple international projects.
Preferred Skills:
- Advanced degree in Science, or related field.
- Experience with digital regulatory platforms and dossier preparation tools.
- Familiarity with nanomaterial, fragrance allergen, and CMR substance regulations.
Contract Details:
- Flexible hours and remote work.
- Project based engagement.
- Opportunity to shape regulatory strategy for innovative beauty and personal care products.