Senior Regulatory Specialist

Job Location: ​Chicago​

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 and Jelly Belly confectionary and dietary supplement branded products. The Senior Regulatory Specialist is experienced with global formulation and labeling requirements, including, but not limited to, Codex, FDA, CFIA, FSANZ, FSA, CFDA, COFEPRIS, 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. 
Create formula assessment reports for the business to document global compliance.
Independently create and validate the technical label copy (FLS) through application of regulations (e.g., Codex, FDA, CFIA, FSANZ, FSA, CFDA, COFEPRIS, etc.) and the standards and principles of nutrition and food science.
Collaborate with internal and external 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 global 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 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 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).
 

Skills that will make you successful

Good understanding of raw materials (macro and micronutrients), ingredient functionality, standard of identity, etc. as they pertain to labeling in international markets (e.g. US, Canada, Mexico, European Union, Asia Pacific (APAC), and Latin American (LATAM) markets).
Intermediate knowledge of international food and dietary supplement law and regulations and comfort with independent regulatory interpretation in international markets, (e.g. US, Canada, Mexico, European Union, Asia Pacific (APAC), and Latin American (LATAM) markets)
Intermediate knowledge of Kosher, Non-GMO project Verified, Gluten-Free Certified, and Organic international product and facility audit requirements (e.g. US, Canada, Mexico, European Union, Asia Pacific (APAC), and Latin American (LATAM) markets).
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
Bilingual preferred

Experiences that will support your success

B.S. in Food Science, Nutrition, Biology, or related field required, MS preferred.
7 years of experience working for an international food or dietary supplements manufacturer with minimally five years of experience in the application of international labeling regulations for a Consumer-Packaged Goods company