Job Title: Regulatory Specialist

Job Description

We are seeking a dedicated Regulatory Specialist based in Chicago, IL. This role involves ensuring compliance with FDA regulations and standards in product labeling and commercialization projects.

Responsibilities

• Create ingredient statements and nutrition fact panels.
• Review and approve raw material and formula compliance through FDA regulations and standards within PLM.
• Provide ingredient, formula, claim, labeling, and regulatory guidance to cross-functional teams on commercialization projects, including formula renovations, ingredient supply chain continuity, and formula line extensions.
• Work cross-functionally to review label content to ensure regulatory standards.
• Work within SAP PLM to review and approve ingredients, formulas, and graphics.
• Research and stay abreast of upcoming regulatory changes, as well as identify and assess regulatory risks in commercialization projects.
• Develop SOPs with related trainings.
• Co-lead third-party certification audits.

Essential Skills

• Experience with CFR21 and FDA regulations.
• Proficiency in SAP and food regulatory standards.
• Ability to write ingredient statements and nutrition fact panels.
• Experience reviewing ingredients, formulas, and graphics.
• 2+ years of experience in a food regulatory position following US FDA regulations.

Additional Skills & Qualifications

• Familiarity with PLM or SAP systems is a plus.
• Experience with Dragonfly, food label review software, PLM, artwork review.
• Knowledge of DSHEA regulations.

Work Environment

This is a remote position with a preference for local candidates, ideally in the CST time zone. The work hours are Monday to Friday, 8 AM to 4 PM, with flexibility to adjust to 7 AM to 3 PM or 9 AM to 5 PM. The position is expected to extend to Q1 of 2027.