Freelance Director of Regulatory Affairs - Food Supplements (U.S. & EU)

Location: Remote

Contract Type: Freelance / Consultant

Reports To: EVP Regulatory Affairs

Position Overview:

We are seeking a highly experienced Regulatory Affairs Director with expertise in food supplements across both U.S. and EU markets. This freelance role is ideal for a strategic thinker and hands-on expert who can ensure compliance, manage regulatory submissions, and guide product development in accordance with complex and evolving legislation.

Key Responsibilities:

Regulatory Strategy & Compliance

- Develop and execute regulatory strategies aligned with:

  - U.S. regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Dietary Supplement Health and Education Act (DSHEA).

  - EU regulations, including Directive 2002/46/EC, Regulation (EC) No 1925/2006 on fortified foods, and Regulation (EU) 2015/2283 on novel foods.

- Ensure product labeling, claims, and marketing materials comply with:

  - FDA rules on health claims, nutrient content claims, and structure/function claims.

  - EFSA guidance on safety, bioavailability, and tolerable upper intake levels for micronutrients.

Product Development Support

- Advise on regulatory implications of formulations and claims.

- Review technical documentation, ingredient dossiers, and safety data for compliance.

Submission & Communication

- Prepare and manage:

  - New Dietary Ingredient Notifications (NDINs) for the U.S. market.

  - Novel Food applications and health claim dossiers for the EU.

- Liaise with FDA, FTC, EFSA, and national competent authorities.

Risk Management & Documentation

- Conduct regulatory risk assessments and develop mitigation strategies.

- Maintain comprehensive regulatory documentation and audit readiness.

Qualifications:

- 10+ years' experience in regulatory affairs, with a focus on food supplements.

- Proven success navigating FDA, FTC, and EFSA regulatory pathways.

- Strong understanding of:

  - CGMPs, labeling regulations, and adverse event reporting in the U.S.

  - Novel Food safety assessments, micronutrient bioavailability, and EU additive regulations.

- Excellent communication, analytical, and project management skills.

- Ability to work independently and manage multiple international projects.

Preferred Skills:

- Advanced degree in Nutrition, Food Science, or related field.

- Experience with digital regulatory platforms and dossier preparation tools.

- Familiarity with botanical and liposomal supplement regulations.

Contract Details:

- Flexible hours and remote work.

- Retainer or project-based engagement.

- Opportunity to shape regulatory strategy for innovative health products.