Regulatory Manager at Clean Simple Eats

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.

Key Responsibilities:

Regulatory Compliance & Oversight:

• 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.

Labeling & Claims Compliance:

• Review and approve product labels, ensuring compliance with FDA labeling regulations, including supplement facts, ingredient listings, and claims.
• Validate structure/function claims and manage substantiation documentation.
• Collaborate with marketing teams to ensure advertising and promotional materials meet regulatory guidelines.

Regulatory Documentation & Submissions:

• Prepare and maintain regulatory documentation, including product dossiers, GRAS notifications, and NDI submissions if applicable.
• Oversee the collection and maintenance of Certificates of Analysis (COAs), safety data, allergens, composition, certifications (organic, kosher, gluten-free, etc.) and technical documentation from suppliers for raw materials and ingredients.
• Manage product registrations, certifications (e.g., NSF, USDA Organic, Non-GMO), and compliance filings.
• Manage registration for retail partners including WERCS.

Cross-Functional Collaboration & Risk Management:

• Partner with product development to assess the regulatory feasibility of new ingredients and formulations.
• Work closely with quality and supply chain teams to ensure vendor compliance and ingredient traceability.
• Provide regulatory guidance and risk assessments for business decisions related to product development and marketing strategies.
• Support the legal team in addressing regulatory inquiries and potential enforcement actions.

Qualifications & Skills:

• 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, including FDA, FTC, DSHEA, and cGMP requirements.
• Experience reviewing and approving supplement labels and marketing claims.
• Strong analytical skills with the ability to interpret complex regulations and provide practical business guidance.
• Excellent communication and collaboration skills for working with cross-functional teams.
• Detail-oriented with strong organizational and project management skills.

Preferred Experience:

• Experience with third-party certifications such as NSF, USP, or Informed Choice.
• Knowledge of Amazon supplement compliance requirements is beneficial.

Salary: $105,000-$120,000 annually

Location: Utah preferred, Hybrid (for candidates local to the Riverton/Salt Lake City area) or Remote

Position Type: Full-time

Benefits: 

• Paid time off (flexible)
• Paid holidays
• Insurance: Health, dental & vision
• 401(k) + Company match
• Free product allowance