Regulatory Affairs Specialist II

Responsibilities

• Provide Regulatory Leadership for Innovation & Commercialization (55%)
• Serve as the regulatory representative on cross-functional project teams
• Review formulations, supplier documentation, claims, ingredient statements/nutrition information, and labels
• Interpret regulations to recommend compliant and commercially viable pathways
• Identify regulatory risks early and propose mitigation strategies
• Provide ongoing regulatory support for existing products
• Monitor regulatory changes and translate impacts into actionable changes
• Lead regulatory activities supporting third-party certifications
• Manage state and federal Food facility registrations and product registrations for Kingsford

• Bachelor of Science degree in a relevant technical field (e.g., Food Science, Nutrition, Chemistry, Biology)
• 4+ years of FDA Foods regulatory experience within the CPG industry
• Strong working knowledge of FDA regulations (e.g., FD&C Act) and Canadian regulatory frameworks
• Hands-on experience with third-party certifications (e.g. Kosher, Halal, Organic)
• Experience with state and federal registrations and a solid understanding of the FDA enforcement landscape
• Demonstrated ability to develop regulatory strategies, assess risk, and influence cross-functional teams
• Strong written and verbal communication skills
• Highly organized and detail-oriented, with the ability to manage multiple priorities

Expertise in FDA regulations and compliance, with a strong focus on risk assessment and regulatory strategy development. Proven ability to lead cross-functional teams and manage product registrations and certifications in the CPG industry.

• FDA Foods Regulatory Experience
• Regulatory Strategy Development
• Third-Party Certifications Management
• State and Federal Registrations
• Cross-Functional Team Leadership

• Regulatory Leadership
• Risk Assessment
• Regulatory Compliance
• Formulation Review
• Ingredient Statement Analysis
• Label Review
• Regulatory Change Monitoring
• Commercial Viability Assessment
• Nutrition Information Review
• Regulatory Documentation

• Strong Written Communication
• Strong Verbal Communication
• Highly Organized
• Detail-Oriented
• Ability to Manage Multiple Priorities

• Kosher Certification
• Halal Certification
• Organic Certification

• CPG Industry
• FDA Regulations
• FD&C Act
• Canadian Regulatory Frameworks
• Food Facility Registrations
• Product Registrations
• Regulatory Risks
• Cross-Functional Project Teams
• Supplier Documentation
• Claims Review