Responsibilities

• The Regulatory Specialist works closely with the other food scientists, Specifications, Marketing, Procurement, Project Management, Legal, and Quality teams. Provides support to other teams as necessary.
• Provides nutritional, labeling, and regulatory expertise such that the business goals of the divisions are supported and advanced to ensure regulatory compliance and responsible marketing and sales actions.
• Holds foundational knowledge of raw materials (macro and micro nutrients), ingredient functionality, standard of identity, etc. as they pertain to labeling.
• Maintains Genesis records to support FDA label compliance standards.
• Independently writes and validates the technical label copy through application of FDA regulations and the standards and principles of nutrition and food science.
• Independently reviews and substantiates claims. Provides regulatory guidance on claims to the organization.
• Reviews and approves label art files in conjunction with cross-functional teams.
• Stays abreast of current FDA regulations and helps assess impact on labeling of our product portfolio.
• Provide technical guidance as appropriate in response to product-related consumer inquiries.
• Maintains a proactive approach by identifying and implementing opportunities for continuous improvement in all aspects of the team’s operation and in the business as related to labeling, regulatory and nutrition.
• Creates and develops Standard Operating Procedures (SOPs) with related trainings.
• Grows internal regulatory team capabilities.
• Provide regulatory and technical input throughout all phases of New Product Development (concept through commercialization)
• Lead assigned product development projects from concept through commercialization.
• Lead/support the planning, execution and reporting of plant trials and product validations for new products and reformulations.
• Safely operate, clean, and maintain lab-ware and equipment while adhering to GMPs in the handling and preparation of food products.
• Other duties and projects as assigned.
  
  

Will need to travel as requested, less than 20%.

Qualifications

B.S. in Food Science, Nutrition, Biology, Engineering or related field required, MS preferred

5 years of experience working for a food manufacturer with minimally three years of experience in the application of government labeling regulations for a Consumer Packaged Goods company

Knowledge of FDA food labeling regulations and comfort with regulatory interpretation

Demonstrated experience working with: ESHA Genesis or similar food labeling program, SAP, Microsoft Office suite, Label Review software (Dragonfly or similar), SharePoint, and knowledge of PLM system

Experience working cross-functionally in a regulatory or labeling environment

High level of demonstrated ability managing multiple priorities with tight deadlines