The Regulatory Manager will oversee compliance with all applicable U.S. regulations for dietary supplements and food products, ensuring products meet FDA, FTC, DSHEA, and other relevant requirements. This role will work cross-functionally with product development, quality, legal, and marketing teams to ensure labeling, claims, and formulations align with regulatory guidelines. The ideal candidate has a strong background in regulatory affairs within the supplement industry and is adept at managing documentation, approvals, and risk assessments. This position reports to the Vice President of Sourcing & Vendor Relations, and may require occasional travel plus the ability to lift up to 50 pounds.

In Short

Ensure all dietary supplements comply with FDA, DSHEA, and cGMP requirements.
Review and approve product formulations, ingredient sourcing, and supplier documentation for regulatory compliance.
Monitor evolving regulatory changes and proactively update internal stakeholders on potential impacts.
Ensure all claims (packaging, website, marketing materials) comply with FTC and FDA regulations.
Review and approve product labels, ensuring compliance with FDA labeling regulations.
Validate structure/function claims and manage substantiation documentation.
Collaborate with marketing teams to ensure advertising and promotional materials meet regulatory guidelines.
Prepare and maintain regulatory documentation, including product dossiers and submissions.
Partner with product development to assess the regulatory feasibility of new ingredients.
Provide regulatory guidance and risk assessments for business decisions.

Requirements

Bachelor’s degree in Food Science, Nutrition, Regulatory Affairs, or a related field; Master’s or RAC certification preferred.
5+ years of regulatory experience in the dietary supplement, food, or pharmaceutical industry.
In-depth knowledge of U.S. dietary supplement regulations.
Experience reviewing and approving supplement labels and marketing claims.
Strong analytical skills with the ability to interpret complex regulations.
Excellent communication and collaboration skills.
Detail-oriented with strong organizational and project management skills.