Regulatory Compliance Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensures compliance with FDA regulations, including 21 CFR Part 117 (Preventive Controls for Human Food), food labeling requirements, and allergen control regulations.
• Ensures compliance with the Pasteurized Milk Ordinance (PMO) requirements, as applicable, and coordinates activities with state dairy regulatory authorities.
• Interprets proposed and evolving regulatory requirements, assesses business impact, and leads implementation of required changes across the organization.
• Serves as the primary liaison with regulatory agencies, including FDA and state authorities, as well as certification bodies.
• Led preparation for, participation in, and response to regulatory inspections, audits, and inquiries.
• Oversees governance and verification of certifications and claims, including Organic, Kosher, Halal, and Non-GMO Project Verified.
• Provides regulatory leadership for product formulation, ingredient compliance, labeling, claims substantiation, and change management.
• Reviews formulations, ingredients, suppliers, labels, and process changes to ensure continued regulatory and certification compliance.
• Provides clear, risk-based regulatory guidance to internal stakeholders.
• Leads export regulatory compliance activities, including facility and process registrations for global markets.
• Partners with Sales, Marketing, Customer Service, and external organizations to support country-specific export documentation and market access.
• Oversees the annual cross-functional process for completing USMCA tariff determinations.

Team Leadership & Program Governance

• Leads, mentors, and develops a team of regulatory professionals through goal setting, coaching, and performance management.
• Ensures regulatory and certification activities are appropriately resourced, prioritized, and aligned with business needs.
• Develops and maintains regulatory policies, procedures, and training programs to promote compliance and continuous improvement.

Qualifications

• Bachelor’s degree in Food Science, Chemistry, Biology, Regulatory Affairs, or a related scientific field, required.
• 5 to 8+ years of regulatory experience in a food manufacturing environment, required.
• Demonstrated working knowledge of FSMA Preventive Controls (21 CFR Part 117), required.
• Experience with PMO regulations in dairy manufacturing environments, required.
• Experience managing product certifications and claims (e.g., Non-GMO, Organic, Kosher, Halal), required.
• Experience supporting export regulatory requirements and global market access, required.
• Proven experience leading and developing regulatory or technical teams, required.