Compliance

• Act as the Responsible Person for designated Norgine entities and Wholesale Distribution Licences
• Ensure compliance with EU GDP requirements and applicable regulations
• Lead inspection readiness activities and support regulatory inspections
• Oversee outsourced distribution activities and third-party compliance
• Support product recalls, investigations, audits, and risk management activities
• Develop and maintain quality procedures, policies, and training programmes
• Provide expert advice to internal stakeholders on quality and compliance matters
• Drive continuous improvement across quality and distribution processes

Quality Compliance Officer, Responsible Person (RP)

• Implement Breakthrough T1D’s regulatory strategy in the EU to accelerate the development, evaluation, and regulatory approval of therapies for type 1 diabetes
• Provide regulatory leadership across Breakthrough T1D’s EU activities, focusing on regulatory affairs and science, evidence generation, clinical trial design, and ecosystem partnerships
• Develop solutions to regulatory and regulatory science challenges, including biomarkers, surrogate endpoints, clinical outcome assessments, digital-health technologies, and real-world data/evidence
• Help shape regulatory priorities, perspectives, and policies across the EU T1D development ecosystem
• Build and maintain relationships with T1D experts and regulatory stakeholders, including the European Medicines Agency and national competent authorities
• Engage industry partners to address regulatory challenges and advance T1D product development
• Provide regulatory guidance to Breakthrough T1D-funded researchers and initiatives
• Track and evaluate EU legislative and regulatory policy developments and identify implications and opportunities
• Report progress and advise Breakthrough T1D leadership on EU regulatory issues
• Identify needs for outside regulatory advisors or consultants and oversee their work
• Collaborate with Breakthrough T1D Affiliates and Research, Advocacy, and Medical Affairs teams
• Perform other duties as assigned

Director, Regulatory Affairs – Europe

• Lead a global team of data stewards and oversee the Regulatory Data Hub
• Advocate for regulatory data integrity, quality, trustworthiness, and responsible stewardship
• Establish and maintain data governance policies, standards, definitions, and business rules
• Oversee regulatory data ownership and stewardship for accuracy, consistency, and global health authority compliance
• Enable data stewards and domain owners to establish metrics, conduct root-cause analysis, prioritize remediation, and measure improvement
• Chair the cross-functional Regulatory Data Council
• Reconcile central, regional, and local GRA business needs
• Provide day-to-day business ownership of the Regulatory Data Hub
• Collaborate with IT and Data, Data Science and Artificial Intelligence teams on regulatory data use cases
• Provide strategic input to tools and processes for collecting, sharing, submitting, and tracking regulatory data
• Lead data governance and stewardship for Unified Regulatory Platform transformation
• Support submission-excellence, AI, automation, simulation, eLabeling, and MDM initiatives
• Lead and develop global data stewards and experts through direct and indirect reporting relationships
• Partner with Process Office and Decision Enablement leads to connect data standards, process design, and decision-ready insights

Director, Regulatory Data Office

• Lead a global team of data stewards and oversee the Regulatory Data Hub (RDH)
• Advocate for regulatory data integrity, business relevance, quality, trustworthiness, and responsible stewardship
• Establish and maintain data governance policies, standards, definitions, and business rules
• Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements
• Enable Data Stewards and Domain Owners to establish and monitor data quality metrics, conduct root-cause analysis, prioritize remediation, and measure improvement
• Chair the cross-functional Regulatory Data Council and govern regulatory data access and ingestion
• Reconcile central, regional, and local GRA business needs
• Provide day-to-day business functional ownership of the Regulatory Data Hub
• Collaborate with JJT (IT) and DDSAI on regulatory data management and business use cases
• Provide strategic input to tools and processes for collecting, sharing, submitting, and tracking regulatory data
• Lead regulatory data governance for end-to-end RIM transformation through the Unified Regulatory Platform
• Support submission-excellence and next-generation submission efforts, including responsible AI, automation, and simulation adoption
• Partner across R&D and the enterprise on eLabeling, MDM/DSI, and other transformation initiatives
• Lead and develop global data stewards and experts through direct and indirect reporting relationships
• Partner with Process Office and Decision Enablement leads to connect data standards, process design, and decision-ready insight

Director, Regulatory Data Office Leader

• Monitor Global Trade Management (GTM) system transactions on hold and take necessary action
• Assign, validate, and maintain customs tariff classifications (HS / CN / TARIC), ECCN classifications and Country of Origin data for globally traded products
• Perform Restricted Party Screening (RPSL/DPL) and support export control and sanctions compliance activities, including due diligence reviews and escalations
• Support daily import/export operations, including review of shipping and customs documentation, customs clearance support, and coordination with customs brokers and freight forwarders
• Assist with Free Trade Agreement (FTA) validations, End User Agreements, and other import/export compliance documentation requirements
• Support maintenance and continuous improvement of trade compliance programs, procedures, ERP/GTM data, and internal controls
• Monitor regulatory changes impacting import/export activities and support implementation of required business process updates
• Investigate and follow up on shipment delays, customs issues, and documentation discrepancies
• Partner with cross-functional teams including Customer Care, Distribution, Procurement, Service & Repair, Tax & Finance, QA/Regulatory, and Transportation to support trade compliance requirements
• Support audits, compliance reviews, and other Trade Compliance projects as assigned
• Assist global offices as needed
• Support compliance with EU Customs, EU export, export control, sanctions, and other trade compliance requirements related to acquisition projects

Compliance jobs in Belgium

Quality Compliance Officer, Responsible Person (RP)

Director, Regulatory Affairs – Europe

Director, Regulatory Data Office

Director, Regulatory Data Office Leader

Import/Export Compliance Specialist