Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for ensuring food and dietary supplement products comply with applicable U.S. and international regulatory requirements, with a strong focus on FDA labeling compliance, including Nutrition Facts/Supplement Facts panels, ingredient statements, claims, and required substantiation.

This role also serves as a regulatory project lead, managing timelines, deliverables, and communications with external regulatory consultants and law firms, while maintaining regulatory data and documentation within Spec Right, Trace Gains, or similar systems. The position partners closely with QA, Marketing, and Sales to support compliant and on-time product launches.

• Review and approve product labels in accordance with FDA regulations, including:
  • Supplement Facts Panel (21 CFR 101.36)
  • Ingredient statements, allergen declarations, and required disclosures
• Review and assess nutrient content claims, structure/function claims, and marketing claims.
• Ensure appropriate substantiation documentation is available, complete, and aligned with label and marketing claims.
• Provide clear regulatory guidance and risk assessments to internal stakeholders.

• Serve as the primary regulatory point of contact for external consultants, law firms, and regulatory service providers.
• Manage regulatory projects end-to-end, including:
  • Timelines and milestones
  • Document requests and review cycles
  • Consolidation of consultant feedback
  • Translate external regulatory guidance into clear internal action items.
• Ensure deliverables from consultants align with FDA requirements and internal standards.

• Apply FDA regulations across both conventional foods and dietary supplements, including:
  • Category-specific labeling and claim requirements
• Support regulatory decision-making during new product development, reformulation, and line extensions.
• Monitor regulatory changes and proactively communicate potential impacts.

• Review and maintain regulatory data within Spec Right, Trace Gains, or similar specification management systems.
• Ensure accuracy and consistency of:
  • Regulatory attributes and documentation
• Support customer-specific regulatory requirements through structured documentation.
• Ensure proper version control and traceability of regulatory records.

• Review packaging artwork to ensure regulatory compliance prior to print or release.
• Partner with Marketing, R&D, QA, Packaging, and Supply Chain teams to implement compliant label language.
• Participate in cross-functional project meetings to support launch readiness and regulatory alignment.

• Support regulatory reviews for international markets (e.g., Canada, Mexico, UK, EU, China) as needed.
• Identify labeling gaps and documentation requirements for export products.

Master’s or PHD degree in Food Science, Nutrition, Regulatory Affairs, or a related field.

3+ years of regulatory experience in the food and dietary supplement industry.

• Demonstrated experience reviewing:
  • FDA Nutrition Facts and Supplement Facts panels
  • Ingredient statements and allergen declarations
  • Claims and claim substantiation documentation
• Proven project management experience, including managing external regulatory consultants or law firms.
• Hands‑on experience using Spec Right, Trace Gains, or comparable specification / regulatory management systems.

• Strong working knowledge of FDA food and dietary supplement regulations.
• Experience managing regulatory documentation within digital systems.
• Ability to synthesize complex regulatory feedback into actionable guidance.
• Strong organizational and time‑management skills to manage multiple projects simultaneously.

• High attention to detail and sound regulatory judgment
• Clear written and verbal communication
• Collaborative, solutions-oriented mindset