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.