Regulatory Affairs Manager

The Regulatory Affairs Manager is responsible for managing the day-to-day regulatory compliance activities for Calbee America’s products, packaging, ingredients, and manufacturing operations. This position supports regulatory strategy through the execution of label reviews, specification management, certification programs, supplier compliance activities, and regulatory documentation. The Regulatory Affairs Manager partners closely with R&D, Quality Assurance, Marketing, Operations, Procurement, Packaging, and external suppliers to ensure compliance with applicable FDA, USDA, FSMA, Canadian, and international regulatory requirements while supporting business growth and innovation.

The role serves as a key resource for regulatory guidance, audit readiness, product commercialization, and certification maintenance. This position is a key member of the Calbee America Corporate Quality Department and reports directly to the Director of Compliance and Regulatory Affairs.

• Support the implementation and maintenance of Calbee America's regulatory compliance programs.
• Monitor and interpret applicable FDA, USDA, FSMA, state, Canadian, and international regulatory requirements.
• Assist in evaluating regulatory impacts of new products, ingredients, packaging changes, and process modifications.
• Maintain awareness of emerging regulatory trends and communicate potential business impacts to management.
• Assist in preparing responses to regulatory inquiries and customer requests.

• Conduct regulatory review and approval of product labels, packaging artwork, ingredient statements, allergen declarations, and Nutrition Facts Panels.
• Verify compliance of product claims, including structure/function claims, nutrient content claims, organic, Non-GMO, Kosher, Gluten-Free, and other certification claims.
• Partner with Marketing and Packaging teams to ensure compliant labeling throughout the graphic approval process.
• Support product commercialization by reviewing formulas, processing methods, and ingredient documentation.

• Maintain ingredient, packaging, finished product, and supplier specifications within company systems.
• Review and approve technical documentation including Certificates of Analysis, product specifications, ingredient statements, and technical data sheets.
• Ensure accurate maintenance of regulatory records and product documentation.
• Support customer, retailer, and certification body information requests.

• Support supplier qualification and approval activities.
• Review supplier regulatory documentation, certifications, and quality agreements.
• Assist in managing compliance requirements for co-manufacturers, ingredient suppliers, and packaging vendors.
• Follow up on corrective actions resulting from supplier audits and compliance assessments.

• Coordinate and maintain third-party certification programs including:
  • Non-GMO Project
  • Kosher
  • Organic
  • Gluten-Free
  • Other customer or regulatory certifications as required
• Prepare certification documentation and support annual renewals and audits.
• Serve as a primary contact for certification agencies and certification-related inquiries.

• Support readiness for FDA inspections, SQF audits, customer audits, and other regulatory assessments.
• Assist with collection and preparation of regulatory records during inspections and audits.
• Participate in corrective action development and verification activities.

• Provide regulatory guidance to R&D, Marketing, Operations, Procurement, and Quality teams.
• Support training initiatives related to…