Compliance

• Serve as a key compliance resource for Mexico
• Partner with business leaders and corporate functions to identify and mitigate compliance risks
• Strengthen the company’s culture of integrity and support implementation of the global Ethics & Compliance program
• Lead and conduct complex, sensitive and confidential internal investigations
• Assess allegations, determine investigative scope and methodology, identify witnesses and documentation, and develop investigation plans
• Conduct or oversee witness interviews, document reviews, fact-finding and other investigative procedures
• Partner with Legal, HR, Internal Audit, Security, Finance and other functions to manage and escalate investigations
• Prepare investigation reports documenting facts, findings, conclusions and recommended remediation
• Determine investigation escalation, interim measures, disciplinary considerations and remediation
• Maintain confidentiality, documentation, records and chain of custody of investigative materials
• Identify trends, systemic issues, root causes and control weaknesses and recommend corrective actions
• Support development and improvement of investigation protocols, procedures, tools and best practices across Mexico and the Americas
• Advise business leaders and stakeholders on ethics and compliance matters
• Implement and enhance the Ethics & Compliance program in Mexico and Latin America
• Conduct compliance risk assessments and develop risk-based action plans and control enhancements
• Own and support compliance monitoring, testing and risk-driven reviews
• Track, analyze and trend compliance cases, control gaps, root causes and remediation actions
• Partner with business and functional leaders to embed ethical decision-making and compliance practices
• Develop and deliver risk-based ethics and compliance training
• Execute local compliance communications and awareness initiatives
• Provide guidance on policies, procedures and compliance requirements
• Establish relationships with senior business leaders and serve as a trusted compliance advisor
• Collaborate with Legal, HR, Finance, Internal Audit, Supply Chain, Procurement, Operations and other control functions
• Support third-party compliance processes, including risk assessment, due diligence, contractual requirements and ongoing monitoring
• Monitor regulatory and business developments relevant to Mexico and Latin America
• Support regional and global Ethics & Compliance initiatives and projects

Manager, Ethics & Compliance

• Contribute to the compliance, validity, periodic reporting, and defense of the VAT & IEPS Certification (Anexo 30), IMMEX, and PROSEC programs
• Evaluate and audit pedimentos and data glosses generated by the external customs broker
• Ensure customs broker legal criteria and classifications align with company interests and mitigate SAT fines
• Perform deep-dive audits on Anexo 24 balances and fixed asset regularizations
• Validate that the legal file consolidated by the analyst complies with statutory record-keeping obligations
• Interpret changes in customs legislation, USMCA (T-MEC) rules, and SAT criteria
• Design customs optimization strategies, efficient regularizations, and shop-floor best practices
• Act as a liaison with the customs broker or authorities during customs incidents, cargo seizures, or SAT inquiries
• Resolve complex operational crises or discrepancies with customs authorities or the broker

Trade Compliance Specialist

• Execute and control customs compliance processes for the IMMEX operation
• Maintain the integrity of master data within the Anexo 24 system
• Assemble the corporate legal archive in coordination with the external customs broker
• Input, upload, and register part numbers, BOMs, and cost structures into the compliance system using SAP data
• Follow up with Engineering and Purchasing to keep information up to date
• Compile, review, and organize the electronic foreign trade file
• Ensure the Customs Broker provides supporting documentation in compliance with Articles 6, 36, and 36-A of the Mexican Customs Law
• Execute manufacturing inventory discharges and reconcile pedimentos for temporary import inventories under Anexo 24 / Anexo 30
• Assign and validate LIGIE tariff codes and NICOs for raw materials and standard components
• Support traffic operations by reviewing cross-border documentation or tracking shipments during peak workloads

Trade Compliance Analyst

• Lead product compliance and certification activities for new and existing products
• Advise product development teams and identify regulatory risks throughout the product lifecycle
• Develop, review, and maintain environmental and regulatory compliance documentation
• Monitor regulatory changes and lead implementation of compliance requirements
• Lead product certification projects and coordinate testing, validation, and approvals
• Partner with Legal, Product Management, Quality, Procurement, Supply Chain, and Marketing teams
• Support customer, supplier, and regulatory inquiries
• Oversee supplier material compliance data collection, review, and validation
• Maintain and improve compliance processes, tools, databases, and Product Data Management records
• Lead assessments for TSCA, California Proposition 65, RoHS, REACH, and other chemical and material regulations
• Support sustainability and environmental reporting initiatives
• Conduct compliance risk assessments and develop corrective action plans
• Mentor junior engineers and cross-functional team members
• Drive continuous improvement to enhance compliance, reduce certification cycle times, and support global market access

Senior Product Compliance Engineer

• Conduct regulatory compliance reviews of raw materials used in flavors, food ingredients, and related products
• Obtain, review, and evaluate supplier documentation to determine ingredient compliance and approval status
• Assess regulatory, scientific, and technical information against global regulations, customer requirements, and internal policies
• Support R&D, Creative, Quality Assurance, Production, and other functions with regulatory guidance
• Identify potential compliance risks and provide recommendations for resolution
• Maintain regulatory records, approvals, and supporting documentation
• Support the evaluation and introduction of new raw materials into the company portfolio
• Manage multiple compliance reviews while meeting project timelines and business priorities
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle

Global Specialist, Regulatory Affairs

• Support execution of multi-product global regulatory CMC for marketed products
• Contribute to preparation and submission of regulatory CMC documentation
• Provide regulatory support to various cross-functional teams
• Execute commercial Lifecycle Management strategy and submissions focused on US, Canada and EU
• Review CMC sections of regulatory submissions and interactions and responses with regulatory agencies
• Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
• Participate effectively on cross-functional teams
• Serve as the primary regulatory CMC contact for assigned products and projects when applicable

Senior Regulatory Consultant – LATAM, Biologics, CTA

• Support regulatory submissions, site activation, and maintenance for awarded projects
• Plan, initiate, and track documents required for regulatory submissions
• Collect, review, and provide country, site, and ethics committee requirements
• Support end-to-end site start-up from site identification through site activation and maintenance
• Serve as the primary point of contact for sites and country-level regulatory and site activation activities
• Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents
• Review and advise on country timelines
• Communicate submission status and action plans to the Regulatory Affairs Manager and project team
• Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents
• Track regulatory documents by site and country and follow up as needed
• Identify country/site risks and develop mitigation strategies
• Advise on country regulatory strategies
• Maintain communication with sites to ensure timely completion of start-up and maintenance activities
• Provide updates on changing regulatory requirements and support interpretation of new regulations
• Maintain the regulatory intelligence database for the assigned country
• Comply with SOPs, ICH GCP, and applicable regulations
• Perform local quality control of submission dossiers when required
• Act as a contact point for translation review of submission documents
• Perform other assigned duties

Specialist, Regulatory and Site Activation

• Support regulatory submissions, site activation, and maintenance for awarded projects
• Serve as the primary point of contact for sites throughout site start-up, from site identification to activation and maintenance
• Act as the country-level internal point of contact for regulatory and site activation activities
• Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents
• Review and advise on country timelines
• Communicate submission status and action plans to the Regulatory Affairs Manager and project team
• Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents
• Track regulatory documents by site and country and follow up with sites and internal team members
• Identify country- and site-level risks and generate mitigation strategies
• Advise on appropriate country regulatory strategies
• Maintain communication with sites to ensure timely completion of start-up and maintenance activities
• Provide updates on changing regulatory requirements and support interpretation of new regulations
• Maintain the regulatory intelligence database for the assigned country
• Provide local quality control of submission dossiers when required
• Support translation review of submission documents when needed
• Perform other assigned duties

Regulatory and Site Activation Specialist

• Monitor domestic and international shipments subject to security regulations
• Maintain records for exports of ITAR hardware, technical data, and defense services
• Manage jurisdiction determinations and internal correspondence
• Perform license determinations, apply license exceptions and exemptions, and file licenses when applicable
• Prepare reports and analysis supporting business financial decisions and regulatory compliance
• Support the Export Compliance Officer and department management with trade compliance questions, projects, and training
• Support EUC verification and manage EUC record retention
• Provide shipment compliance reports on high-risk customers and products
• Conduct new customer screening for government import/export compliance
• Conduct Denied Party Check reviews for new partner creation and maintain partner information
• Search supplier websites and price books for ECCNs
• Coordinate new part numbers to obtain ECCN certification from the EMEA trade compliance team
• Administer ECCN maintenance and license determination requirements in SAP
• Coordinate review and release of blocked orders in SAP
• Develop and deliver training programs on security requirements
• Monitor case law and legislation for relevant compliance updates
• Research new Denied Persons Lists and BIS news and provide timely business updates
• Identify, investigate, and participate in process and procedure improvement opportunities
• Perform other duties as assigned