Regulatory Affairs Analyst

Regulatory Affairs Analyst

The Regulatory Affairs Analyst is responsible for supporting regulatory compliance, food safety, and quality documentation by managing finished product specifications, technical product data, and regulatory information across multiple enterprise systems. This role partners closely with Quality Systems, Site Quality, Research & Development, Sales, Procurement, Operations, suppliers, and customers to ensure product specifications are accurate, complete, and compliant with customer requirements, regulatory standards, and company policies. The analyst maintains product documentation within systems including SAP, TraceGains, and Product Vision while supporting regulatory initiatives, special projects, and continuous process improvements in a fast-paced manufacturing environment.

This is a remote role; however, you must reside in the Downers Grove, IL area or near one of our plant locations.

Work Schedule:

• Monday - Friday
• 8-5

Key Responsibilities:

• Collaborate with customers and label suppliers to review, update, coordinate, and file finished good labels.
• Evaluate and approve new ingredients in coordination with Procurement and the Supplier Quality team.
• Enter raw material and finished good formula data into Product Vision for further nutritional work by Regulatory Affairs and Product Developers.
• Manage and maintain enterprise-wide Identity Preserved programs and audits (Organic, Gluten Free, Kosher, Halal, Non-GMO, etc).
• Maintain product specification information in customer portals and respond to customer requests.
• Manage regulatory documentation and filing within enterprise systems, including SAP, TraceGains, Product Vision, and customer portals.
• Collaborate with customers, suppliers, Regulatory Affairs, Quality, R&D, Procurement, Sales, Operations, and other cross-functional teams to obtain technical information and ensure compliance with customer requirements, regulatory standards, and company policies.
• Coordinate information gathering across multiple departments to support timely completion of documentation.
• Support food safety and quality functions through accurate data management within enterprise systems.
• Assist the Regulatory Affairs team with special projects and provide backup support for Regulatory Affairs Analyst responsibilities as needed.
• Apply quality strategies and priorities to support continuous improvement initiatives and organizational objectives.
• Communicate project status, priorities, and business impacts effectively to stakeholders.
• Follow Good Manufacturing Practices (GMPs), HACCP principles, food safety standards, and all company safety, health, environmental, and quality policies.

Qualifications:

• Associate's or Bachelor's degree in Food Science, Regulatory Affairs, Quality Assurance, Biology, Chemistry, or a related technical field preferred.
• 3–5 years of experience in data entry, technical product documentation, specification management, or related administrative functions.
• 1–3 years of experience supporting Regulatory Affairs, Research & Development, Food Safety, or Quality in a food manufacturing environment.
• Experience working within Good Manufacturing Practices (GMPs) and Hazard Analysis and Critical Control Points (HACCP) programs preferred.

Knowledge & Technical Skills:

• Working knowledge of food manufacturing processes, product specifications, ingredient documentation, and regulatory compliance.
• Experience using SAP, TraceGains, Product Vision, customer portals, and Microsoft Office Suite, particularly Excel and PowerPoint.
• Understanding of food safety, quality systems, labeling, ingredient documentation, and specification management.
• Strong analytical, organizational, and problem-solving skills with exceptional attention to detail.
• Excellent written, verbal, presentation, and interpersonal communication skills.
• Ability to maintain confidentiality while managing sensitive product and regulatory information.

Competency:

• Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines.
• Ability to work independently while collaborating effectively across cross-functional teams.
• Demonstrated initiative, self-confidence, and the ability to drive process improvements.
• Strong attention to detail with excellent follow-up and recordkeeping skills.
• Ability to interpret technical information, analyze data, and make sound decisions in a fast-paced environment.
• Proficient keyboarding and data management skills.
• Ability to build positive working relationships with employees, management, customers, and suppliers.

Work Environment & Physical Demands:

• Work in a professional office environment requiring frequent collaboration with cross-functional teams, including Regulatory Affairs, Quality Assurance, R&D, Procurement, Operations, and Customer Service.
• Establish and maintain effective working relationships with employees, customers, suppliers, and management at all organizational levels.
• Communicate professionally and effectively through verbal, written, and electronic communication.
• Manage multiple priorities and deadlines while maintaining a high level of accuracy, organization, and attention to detail.
• Exercise sound judgment, maintain confidentiality, and work independently as well as collaboratively in a fast-paced environment.

Physical Demands:

• Primarily performs work in a standard office environment with prolonged periods of sitting and computer use.
• Frequently uses a computer, keyboard, telephone, and other standard office equipment.
• Must be able to communicate effectively in person, by telephone, and through electronic communication.
• Occasionally required to stand, walk, bend, reach, and lift or move office materials weighing up to 15 pounds.
• May occasionally visit production or warehouse areas, requiring adherence to all applicable food safety, personal protective equipment (PPE), and safety requirements.

The information provided in this document provides an overview of the most common duties, qualifications, and demands of the position. It is not intended to be a comprehensive summary of the role, and the duties, qualifications, and demands of the position are subject to change without notice. The expectations provided here may also be modified if an employee with a disability could effectively meet the expectations for the role with reasonable accommodation.

The pay range for this full-time, salaried position is $58,962 - $81,074 /year. Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. The position is eligible for a discretionary annual incentive based on company and individual performance. We offer a comprehensive benefits package including health, dental, 401k and wellness benefits beginning on the first day of employment. This information is provided per the relevant state and local pay transparency laws for the location in which this position will be performed. Base pay information is based on market location.

Maker's Pride is an Equal Opportunity Employer.