Regulatory Scientist

The Company:

Based in Chicago, IL our company categories include baking mixes (cake, brownie, cookies, muffins, etc) ready-to-spread frostings, pancake and waffle mixes, frozen pancakes and waffles, breakfast syrup, and baking ingredients.

Position Overview:

The Scientist, R&D will be joining a private equity “start-up” business with iconic brands, strong retail presence, and outstanding manufacturing capabilities. The role a dual role with 60% regulatory and 40% product development. The Regulatory Scientist is responsible for regulatory aspects like labeling, nutrition, and regulatory guidance as well as food product development. The regulatory responsibilities include broad-based labeling and nutrition guidance, responsibility for the technical accuracy of product labels, and development and maintenance of appropriate records to meet corporate, government, and consumer requirements. The food product development responsibilities include leading product development projects from concept through commercialization. The Company plans to aggressively increase the pace of innovation in the baking, ingredients, and breakfast categories where there is ample opportunity for disruption and differentiation.

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

Personal Characteristics:

• Displays even temperament, ethical values and good team-play within R&D and cross-functionally
• Strong communication skills
• Great attitude and drive: Ability to roll up sleeves and get things done.
• Ability to thrive in a fast-paced environment, can handle moderate degrees of ambiguity.
• Passion for food and innovation.