Regulatory Specialist

$60,008 - $75,005/Yr

Actalent - Naperville Park District, IL

Full-time - Mid Level

Hybrid - Naperville Park District, IL

10,001+ employees

Administrative and Support Services

About the position

The Regulatory Specialist will oversee all aspects of Regulatory Compliance for various facilities, focusing on food regulations. This role requires collaboration with internal departments and a thorough understanding of FDA and USDA regulations to ensure compliance in product labeling and documentation.

Responsibilities

• Create and update ingredient declarations for both new and existing products.
• Create and update nutrition panels for both new and existing products.
• Create, manage, and update all appropriate regulatory documents (e.g., allergen, GMO, Country of Origin, % range breakdown, customer questionnaires, gluten, natural, SDS, etc.).
• Keep current with both FDA and USDA government food/labeling regulations.
• Update appropriate departments and/or members of the company regarding future government regulation changes/updates that will/may affect products.
• Manage the regulatory aspects of exported products.
• Create, proof-read, and update product specifications as needed.
• Coordinate with Marketing and Sales.
• Create and/or assist in creating labels for new and/or current items.
• Proof-read all printed labels, pre-printed packages, and in-line printed labels prior to final printing.
• Coordinate the approval process of all new and updated labels.
• Manage, maintain, and update ingredient files.
• Contact ingredient suppliers for needed ingredient documents.
• Travel to customers, trade shows, industry events, customer events, company meetings, etc. as needed.
• Provide regulatory support to internal and external customers.

Requirements

• 5+ years of experience working in label reviews for FDA-regulated facilities (CPG, food service, etc.).
• Ability to review artwork and create nutrition facts panels and nutrition statements based on FDA regulations.
• Experience working with finished goods regulations.
• Proficiency in regulatory compliance and label artwork review.
• Familiarity with FDA regulations.

Nice-to-haves

• Experience with ProductVision and Genesis is a plus.
• Experience with TraceGains is a plus.
• Knowledge of international regulations is a plus.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)