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Ferrara · 19 hours ago

Sr. Specialist, Regulatory

Chicago, IL

Full-time

Onsite

Senior Level

$80K/yr - $112K/yr

7+ years exp

Ferrara is a company focused on confectionary and dietary supplement products, seeking a Senior Regulatory Specialist to provide technical expertise in ingredient approvals and product formulation. This role involves collaborating with cross-functional teams to ensure compliance with FDA regulations and guiding other regulatory specialists.

ConfectioneryFood and Beverage

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

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)

Qualification

FDA regulationsLabeling requirementsFood Science knowledgeSAPFood Label Review softwareProduct Lifecycle ManagementKosher certificationUSDA Organic certificationInterpersonal skillsAttention to detail

Required

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