Regulatory Affairs Analyst
Maker's Pride · Downers Grove, IL · 2 wk ago
RemoteRemoteLegal$59k–$81k/yrFull-time
Job Summary
The Regulatory Affairs Analyst supports 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.
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.
- Affiliate with 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.
Competencies
- 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
- Primarily performs work in a standard office environment with prolonged periods of sitting and computer use.
- 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.
- Occasional visits to production or warehouse areas, requiring adherence to all applicable food safety, personal protective equipment (PPE), and safety requirements.