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.

Reports To:

QMS Manager

Works closely with: QA/QC, Production, Maintenance, Supply Chain, R&D and Regulatory Teams

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…