Sr. Specialist, Regulatory - Chicago, IL

Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Due to the highly interactive and team-based nature of this role, in-person attendance for most of the workweek (i.e., 3 days or more) is essential for: effective communication including during in-person meetings, strong supervision, real-time problem-solving, and participation in cross-functional initiatives.
Want to make an impact?
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.
Ways you will make a difference
• 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.
• Partners with Scientific Regulatory Affairs team to stay abreast of emerging applicable global regulations and helps assess impact on labeling of our product portfolio.
• Partners 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).
Additional Qualifications/Responsibilities
Skills that will make you successful
• 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
What We Offer
At Ferrara, we're proud to support our employees with comprehensive benefits that enhance health, financial wellness, and include paid time off (PTO). Eligible employees may also receive an annual bonus based on company performance.
Compensation
$85,680.00 to $128,520.00 annually