Regulatory Affairs Specialist

Position Summary:As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory complianceforall productsin accordance withlocal, national, and international regulations and customer requirements. Responsibilities include preparing andsubmittingregulatory documentsin accordance withthe FDA andmanaging supplier compliance records. In the absence of the Regulatory Affairs Specialist, the QARegulatoryManager may temporarily assumeresponsibilities.Essential FunctionsRegulatory Compliance and LabelingEnsure compliance with FDA regulations, including 21 CFR, FSMA Preventive Controls, and applicable state regulationsReview and approve product labels for accuracy, including ingredient statements, Nutrition Facts, allergen declarations, claims, country of origin, and shelf lifeMaintain compliance with FDA labeling modernization updates and customer-specific labeling requirementsReview ingredient specification sheets, nutritional information, and labeling for compliance with company standards and applicable regulationsSupport food safety and regulatory documentation for domestic and international customers, including COAs, product specifications, andFood Safetyregulatory statementsCoordinate, prepare, review, andsubmitregulatory documents requested by customers and regulatory agencies for domestic and international productsin compliance with FDA and international standards.Prepare andsubmitresponses to food safety and quality customer requests for information, including product data, surveys, and questionnairesMonitor and renew FDA facility registrationsKosher CertificationManage Kosher certification programs (KOF-K)Serve as the primary point of contact for Kosher certifying agencies and RabbisReview and approve raw materials, processing aids, and suppliers for Kosher complianceMaintain the Kosher databasePrepare andsubmitKosher certificates in response to customer requestsIngredientsand Supplier ComplianceReview ingredient specifications, supplier documentation, and regulatory approvalsVerify compliance related to allergens, GMO/Non-GMO status, clean label requirements, and customer-specific claimsMonitor ingredient changes and assess regulatory and compliance impactsMaintain regulatory and supplier compliance databases, includingTraceGains, ERP, or equivalent systemsOversee supplier documentation management withinTraceGains, including request initiation, follow-up, review, approval, and upload of food safety and quality recordsFacilitate Certificate of Analysis (COA) verification with accredited external laboratoriesMonitoring and Continuous ImprovementMonitorFood Safetyregulatory changesimpactingthe baking and food manufacturing industryResearch existing and emerging legislation that mayimpactnew and existing product development, providing regulatory interpretation and guidanceCommunicate regulatory updates, risks, and compliance impacts to leadership and cross-functional teamsInterface with regulatory agencies to obtain clarification oradditionalinformation as neededMaintains 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 QualificationsProficient in Microsoft Office (MSWord, Excel, PowerPoint), nutritional databases or equivalent software databases. Excellent analytical abilities, and effective attention to details.Working knowledge of FDA& internationalregulations is preferred.Knowledge ofTraceGainsSupplier PortalEducation/ExperienceMust have BS/BA degree in Food Science or other scientific or technical field and a minimum of1-2years? relevant experience, or an equivalent combination of education and experience in the food manufacturing industry.HACCP Certifiedpreferred.Completed PCQI/ SQFcoursespreferred.Position Training RequirementsNetsuiteSOPs& Supplier Management(Trace Gains)Operations Standard Operating Procedures SOPs:OPER-00016-CST-POLI, Good Manufacturing Practices and RequirementsQuality Standard Operating Procedures SOPs:QUAL-00105-T-POLI, Personal Protective Equipment (PPE) Specifications

Salary : $24