Regulatory Affairs Specialist, I - Rome

Position Purpose · The Regulatory Affairs Specialist I ensures ingredient compliance and supports regulatory data management within the Regulatory team's systems. This role conducts compliance reviews for new and existing ingredients, manages technical request coordination and fu ...

Job description

Position Purpose
The Regulatory Affairs Specialist I ensures ingredient compliance and supports regulatory data management within the Regulatory team's systems. This role conducts compliance reviews for new and existing ingredients, manages technical request coordination and fulfillment, and maintains consistency between TraceGains and PLM for ingredient compliance data. The Specialist I supports supply chain consistency through reviews related to ingredient cost savings, assured supply, and consolidation projects. This role collaborates with internal partners (New Product Development, Procurement, Sales & Marketing, Quality Assurance, Leadership) and external partners (suppliers, agencies, laboratories, consultants) while receiving mentorship from senior regulatory staff.
Primary Responsibilities include:

• Ingredient Compliance Management - Conducts ingredient compliance reviews for new and existing ingredients to ensure regulatory adherence across the supply chain. Conducts ingredient substitution suitability reviews and independently makes decisions concerning such substitutions based on compliance data. Completes ingredient activations in the PLM system as a part of the product activation process.
• Data System Administration - Ensures consistency between TraceGains and PLM systems for ingredient compliance data. Provides PLM support for the regulatory team, specifically maintaining approved constituents for labeling and label set rules. Works with Information Systems to ensure resolution of Regulatory data systems issues and implementation of enhancements.
• Suitability Reviews, Cost Savings Initiatives. - Conducts ingredient compliance reviews and provides feedback in support of supply chain consistency and ingredient consolidation projects for assured supply and cost savings initiatives.
• Technical Request Coordination - Manages coordination and fulfillment of technical requests, customer portals (e.g., Walmart, Kroger), and KPI reporting for fulfillment rate metrics.
• Regulatory Data Management - Coordinates the regular review and update of regulatory data and statements (e.g., Letters of Guaranty), with particular focus on customer-facing data.
• Facility Licensing - Works with Director to ensure the timely maintenance and update of facility licenses, e.g., GA Dept. of Agriculture Seafood Sales.
• Compliance Project Management - Works with Regulatory and cross-functional partners to implement product compliance-driven label changes, ensuring timely execution and stakeholder coordination.

Working Conditions
Must be able to handle multiple tasks. Work is typically sedentary but requires approximately 10-15% of time walking/standing. Can include long periods of time in front of computer. May include travel to plant locations, industry trade association meetings, and other regulatory functions as needed.
Essential Skills

• BS in food science or closely related scientific field or equivalent combination of education and experience (e.g., Associate's degree plus 4 years of relevant food regulatory experience, or 6+ years of relevant food regulatory experience in lieu of a degree).
• 1-3 years relevant experience in food law / compliance.
• Detail-oriented with strong organizational skills
• Familiarity with ERP systems. PLM and TraceGains familiarity a plus
• Working knowledge of FDA, USDA, and other relevant food regulations with an ability to apply them to ingredient compliance decisions
• Strong data management and analytical skills
• Project management capabilities
• Effective verbal and written communication
• Ability to work collaboratively across departments
• Problem-solving and critical thinking abilities