Sr. Specialist, Regulatory

Ferrara • Chicago, IL

95d • $85,680 - $128,520

About The Position

The Senior Regulatory Specialist works cross-functionally on complex and innovative projects to provide technical expertise and support in ingredient approvals, innovative product formulation development, label copy development and maintenance, claim substantiation, and artwork review for Ferrara’s US Iconic, Seasonal, and Jelly Belly branded confectionary and dietary supplement products. The Senior Regulatory Specialist is highly experienced with both US FDA formulation and labeling requirements and possesses leadership skills to guide and mentor Associate Regulatory Specialists and Regulatory Specialists.

Requirements

• B.S. in Food Science, Nutrition, Biology, or related field required.
• 7 years of experience working for a food or dietary supplements manufacturer with minimally five years of experience in the application of government labeling regulations for a Consumer-Packaged Goods company.
• Adept in raw materials (macro and micronutrients), ingredient functionality, standard of identity, etc. as they pertain to labeling.
• Advanced knowledge of 21 CFR FDA food and DSHEA regulations and high level of comfort with regulatory interpretation.
• Strong knowledge of Kosher, Non-GMO project Verified, Gluten-Free Certified, and USDA Organic product and facility audit requirements.
• Demonstrated experience working with SAP, Microsoft Office suite, Food Label Review software, SharePoint, and a Product Lifecycle Management (PLM) system.
• High level of autonomy and strong ability to manage multiple priorities in fast-paced environment, work with ambiguity, and problem solve.
• Strong intra and interpersonal skills.
• Excellent attention to detail with a high degree of accuracy and thoroughness.

Responsibilities

• Independently research information pertaining to ingredient/additive, standard of identity, labeling, and claim substantiation requirements through the navigation of internal and external tools and systems.
• Provide proactive and risk-based regulatory recommendations on ingredient, formula, claim, and labeling to cross-functional stakeholders on complex commercialization projects such as, platform and pipeline innovations.
• Independently create and validate the technical label copy (FLS) through application of FDA regulations and the standards and principles of nutrition and food science.
• Collaborate with cross-functional stakeholders to review label content for accuracy and provide recommendations for required changes.
• Independently review, register, and certify raw materials and finished goods with 3rd party certification bodies (e.g., Kosher, Organic, Gluten-Free certified, non-GMO project verified, etc.)
• Co-lead 3rd party certification audits with the manufacturing Quality team.
• Support Associate Specialists and Specialists in regulatory research and risk-based recommendations.
• Partner with Scientific Regulatory Affairs team to stay abreast of emerging applicable global regulations and helps assess impact on labeling of our product portfolio.
• Partner with external regulatory experts to build internal expertise.
• Provide technical guidance, as appropriate, in response to product-related consumer inquiries.
• Maintain a proactive approach by identifying opportunities for continuous improvement to internal processes.
• Independently develop Standard Operating Procedures (SOPs) with related trainings.
• Undergo training to stay current with FDA food and dietary supplement regulations.
• Act as a back up to the US & Seasonal Regulatory Manager.
• Understand and demonstrate the Company’s core values (empathy, empowering, agile, collaborative, and lead with integrity).
• Perform other duties and special projects as assigned (special projects may require travel to the manufacturing sites).

Benefits

• Comprehensive benefits that enhance health and financial wellness.
• Paid time off (PTO).
• Eligible employees may receive an annual bonus based on company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree