Regulatory Affairs Specialist

Position Summary The Regulatory Affairs Specialist is responsible for ensuring company compliance with all applicable federal, state, and international regulations governing the manufacture, labeling, marketing, distribution, and sale of pet food, treats, supplements, and animal feed supplements. This position serves as the primary regulatory resource for product development, quality assurance, manufacturing, marketing, and commercial teams. The Regulatory Affairs Specialist supports the organization to ensure compliance with FDA regulations, including 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) and 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals), AAFCO model regulations, NASC quality standards, state feed registration requirements, and applicable international regulations. The successful candidate will proactively monitor regulatory developments, ensure labeling compliance, manage product registrations, support product innovation, and assist with regulatory inspections and audits. Reporting Structure Reports To: QMS Manager Works closely with: QA/QC, Production, Maintenance, Supply Chain, R&D and Regulatory Teams Key Responsibilities Regulatory Compliance Interpret and apply requirements of 21 CFR Part 507 and related FDA guidance documents. Monitor regulatory changes and communicate impacts to internal stakeholders. Maintain regulatory documentation, records, and compliance files. Product Registration and Licensing Prepare, submit, and maintain state feed registrations and product licenses. Coordinate product registrations for all U.S. states and applicable international markets. Maintain registration databases and renewal schedules. Respond to inquiries from state feed control officials and regulatory agencies. Reporting and paying tonnage fees. Labeling and Claims Review Review product labels, packaging, inserts, websites, advertisements, social media content, and marketing materials for regulatory compliance. Verify compliance with AAFCO labeling requirements, ingredient definitions, nutritional adequacy statements, guaranteed analyses, and feeding directions. Lead the AAFCO Pet Food Label Modernization (PFLM) project to modernize and update the VPI labels to comply with the requirements. Evaluate product claims for compliance with FDA, NASC, FTC, and applicable state requirements. Collaborate with Marketing and Product Development to develop compliant product messaging. NASC Compliance Support maintenance of NASC Quality Seal certification. Ensure compliance with NASC labeling, adverse event reporting, ingredient review, and quality system requirements. Assist with NASC audits and corrective action activities. Maintain records required under NASC standards. Product Development Support – New Project Portfolio through Commercialization Review formulas, ingredients, specifications, and supplier documentation for regulatory acceptability. Assess ingredient compliance with AAFCO definitions, GRAS determinations, FDA regulations, and state requirements. Provide regulatory guidance during formulation changes and product modifications. Monitor developments from FDA, AAFCO, NASC, state feed control agencies, USDA, FTC, and relevant industry organizations. Evaluate potential business impacts of regulatory changes. Develop implementation plans for new regulatory requirements. Audit and Inspection Support Prepare requested documentation and records. Participate in corrective and preventive action (CAPA) activities. Support regulatory responses and follow-up communications. Adverse Event and Complaint Management Support review and investigation of product complaints and adverse event reports. Ensure reporting obligations are met under NASC and applicable regulations. Collaborate with Quality Management System Team to maintain complaints and adverse event documentation. Cross-Functional Collaboration Work closely with Quality Assurance, R&D, Operations, Supply Chain, Purchasing, Sales, and Marketing teams. Provide regulatory training and guidance to employees. Support risk assessments and compliance initiatives across the organization. Leadership No supervisory responsibilities for this role. Environmental Health and Safety Adhere to all company safety policies and procedures; actively support a safe and healthy work environment. Food Safety and Good Manufacturing Practices (GMP) Follow all Food Safety and Good Manufacturing Practices (GMP) standards to ensure product quality, integrity, and compliance with regulatory requirements. Qualifications Associate’s or Bachelor’s degree in a related scientific field 4+ years of experience in regulatory, quality assurance, quality control, or food safety. Working knowledge of FDA, NASC and AAFCO standards. Work in a food, beverage, pet food, or regulated manufacturing environment. Familiarity with GMPs, HACCP principles, sanitation programs, and quality systems. Experience with inspections, audits, and documentation management. Preferred Requirements Bachelor’s degree in food science, Animal Science, Biology, Chemistry, Regulatory Affairs, or related scientific discipline. HACCP certification or Preventive Controls Qualified Individual (PCQI) certification. Experience working in a GFSI-certified facility. Experience in pet food manufacturing or extrusion processes. Experience with environmental monitoring and microbiological sampling. Familiarity with Quality Management Systems (paper based and electronic), and laboratory testing procedures. Experience managing state feed registrations. Experience with import/export requirements for pet food and animal feed. Experience supporting NASC certification programs. Preferred Certifications Preventive Controls Qualified Individual (PCQI). HACCP Certification. Regulatory Affairs Certification (RAC). Certified Quality Auditor (CQA). NASC Compliance Training or equivalent industry training. Physical & Work Environment Requirements Ability to sit, stand, and work at a computer for extended periods. Ability to review detailed technical and regulatory documentation. Occasional travel (up to 15%) for audits, inspections, trade events, and regulatory meetings. Knowledge, Skills, Abilities and Performance Metrics Working knowledge of 21 CFR Part 507 requirements and 21 CFR Part 117 principles and food safety systems. Knowledge of AAFCO regulations, ingredient definitions, and model bills. Understanding of NASC Quality Seal requirements. Familiarity with state feed registration processes. Knowledge of labeling regulations and claim substantiation requirements. Strong technical writing and documentation skills. Excellent organizational and project management abilities. Ability to interpret complex regulations and communicate requirements effectively. Strong analytical and problem-solving skills. Proficiency in Microsoft Office and regulatory documentation systems. Success in this role may be measured by: Timely completion of state registrations and renewals. Audit and inspection outcomes. Accuracy of labeling and claims reviews. Compliance with NASC requirements. Successful implementation of regulatory changes. Reduction in compliance-related findings and corrective actions. Support of successful product launches without regulatory delays. #J-18808-Ljbffr Vet's Plus