Regulatory Affairs Specialist

Full Job Description

Job Overview

As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory compliance for all products in accordance with local, national, and international regulations and customer requirements. Responsibilities include preparing and submitting regulatory documents in accordance with the FDA and managing supplier compliance records. In the absence of the Regulatory Affairs Specialist, the QA Regulatory Manager may temporarily assume responsibilities.

Essential Functions

Regulatory Compliance and Labeling

• Ensure compliance with FDA regulations, including 21 CFR, FSMA Preventive Controls, and applicable state regulations
• Review and approve product labels for accuracy, including ingredient statements, Nutrition Facts, allergen declarations, claims, country of origin, and shelf life
• Maintain compliance with FDA labeling modernization updates and customer-specific labeling requirements
• Review ingredient specification sheets, nutritional information, and labeling for compliance with company standards and applicable regulations
• Support food safety and regulatory documentation for domestic and international customers, including COAs, product specifications, and Food Safety regulatory statements
• Coordinate, prepare, review, and submit regulatory documents requested by customers and regulatory agencies for domestic and international products in compliance with FDA and international standards
• Prepare and submit responses to food safety and quality customer requests for information, including product data, surveys, and questionnaires
• Monitor and renew FDA facility registrations

Kosher Certification

• Manage Kosher certification programs (KOF-K)
• Serve as the primary point of contact for Kosher certifying agencies and Rabbis
• Review and approve raw materials, processing aids, and suppliers for Kosher compliance
• Maintain the Kosher database
• Prepare and submit Kosher certificates in response to customer requests

Ingredients and Supplier Compliance

• Review ingredient specifications, supplier documentation, and regulatory approvals
• Verify compliance related to allergens, GMO/Non-GMO status, clean label requirements, and customer-specific claims
• Monitor ingredient changes and assess regulatory and compliance impacts
• Maintain regulatory and supplier compliance databases, including TraceGains, ERP, or equivalent systems
• Oversee supplier documentation management within TraceGains, including request initiation, follow-up, review, approval, and upload of food safety and quality records
• Facilitate Certificate of Analysis (COA) verification with accredited external laboratories

Monitoring and Continuous Improvement

• Monitor Food Safety regulatory changes impacting the baking and food manufacturing industry
• Research existing and emerging legislation that may impact new and existing product development, providing regulatory interpretation and guidance
• Communicate regulatory updates, risks, and compliance impacts to leadership and cross-functional teams
• Interface with regulatory agencies to obtain clarification or additional information as needed
• Maintains a positive working environment through collaboration and effective communication
• Demonstrates and adheres to all employee safety, human resources, food safety, and quality requirements, including but not limited to understanding the proper use of PPE (Personal Protection Equipment) and plant specific GMPs (Good Manufacturing Practices)

Minimum Qualifications

• Proficient in Microsoft Office (MSWord, Excel, PowerPoint), nutritional databases or equivalent software databases. Excellent analytical abilities, and effective attention to details.
• Working knowledge of FDA & international regulations is preferred.
• Knowledge of TraceGains Supplier Portal.

Ingredients and Supplier Compliance

• Review ingredient specifications, supplier documentation, and regulatory approvals
• Verify compliance related to allergens, GMO/Non-GMO status, clean label requirements, and customer-specific claims
• Monitor ingredient changes and assess regulatory and compliance impacts
• Maintain regulatory and supplier compliance databases, including TraceGains, ERP, or equivalent systems
• Oversee supplier documentation management within TraceGains, including request initiation, follow-up, review, approval, and upload of food safety and quality records
• Facilitate Certificate of Analysis (COA) verification with accredited external laboratories

Monitoring and Continuous Improvement

• Monitor Food Safety regulatory changes impacting the baking and food manufacturing industry
• Research existing and emerging legislation that may impact new and existing product development, providing regulatory interpretation and guidance
• Communicate regulatory updates, risks, and compliance impacts to leadership and cross-functional teams
• Interface with regulatory agencies to obtain clarification or additional information as needed
• Maintains a positive working environment through collaboration and effective communication.
• Demonstrates and adheres to all employee safety, human resources, food safety, and quality requirements, including but not limited to understanding the proper use of PPE (Personal Protection Equipment) and plant specific GMPs (Good Manufacturing Practices).

Education/Experience

• Must have BS/BA degree in Food Science or other scientific or technical field and a minimum of 1-2 years’ relevant experience, or an equivalent combination of education and experience in the food manufacturing industry.
• HACCP Certified preferred.
• Completed PCQI/ SQF courses preferred.

Position Training Requirements

• Netsuite
• SOPs & Supplier Management (Trace Gains)
• Operations Standard Operating Procedures SOPs: OPER-00016-CST-POLI, Good Manufacturing Practices and Requirements
• Quality Standard Operating Procedures SOPs: QUAL-00105-T-POLI, Personal Protective Equipment (PPE) Specifications

Pay: $46,300.00 – $88,320.00 per year

You may send resumes and applications to: [email protected]