Compliance

• Support the management and implementation of SOPHiA GENETICS' Compliance programs across all markets where products and services are marketed
• Manage healthcare compliance operations, including drafting and reviewing healthcare professional engagement contracts
• Manage declarations to healthcare authorities and ensure adherence to international regulations, local laws, and company compliance standards
• Manage enterprise insurance operations, including policy administration, claims processing, renewals, and insurer coordination
• Execute contract administration and review across healthcare compliance, data protection, information security, and general terms
• Support risk management infrastructure, including maintaining the internal control framework
• Implement mitigation measures and prepare periodic reporting to relevant committees
• Assist with policy writing, training materials, and guidance documentation
• Stay current on developments in risk management and compliance

Compliance Specialist

• Lead end-to-end regulatory activities for assigned Visp client programs
• Act as Regulatory Affairs Project Lead and align regulatory strategy, timelines, and deliverables with program objectives
• Coordinate regulatory workstreams across internal functions and global regulatory affairs networks
• Prioritize, plan, and track regulatory deliverables across concurrent programs
• Oversee day-to-day regulatory activities, including submissions, lifecycle management, and health authority interactions
• Prepare, review, and deliver regulatory documentation, dossier content, health authority responses, and briefing packages
• Support teams in managing competing priorities and resolving operational challenges
• Support customers with CMC strategies aligned with global requirements and expectations
• Ensure regulatory activities comply with applicable guidelines, registered dossiers, and Lonza procedures
• Assess changes, deviations, and lifecycle activities against regulatory filings and strategy
• Support the Lonza Regulatory Information Bulletin
• Serve as the primary regulatory interface for customers on assigned programs
• Build relationships with customers and internal stakeholders including MSAT, Quality, Production, and Supply Chain
• Support customer interactions with health authorities, including meeting preparation, participation, and responses
• Communicate regulatory risks, timelines, and deliverables proactively
• Strengthen regulatory capabilities at the Visp site and support scalability and consistency
• Support inspection readiness and high standards of compliance and documentation
• Identify risks and improvement opportunities and implement mitigation strategies

Regulatory Affairs Manager

• Join the global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products
• Perform EU/EEA regulatory assessments of changes, applying applicable legislation, EU Clinical Trials Regulation requirements and regulatory guidance
• Assess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine appropriate regulatory actions
• Prepare and maintain Summary of Changes documentation
• Manage product-specific changes impacting sIMPDs, SmPCs and clinical labels
• Manage non-product-specific changes impacting manufacturing/release site lists, manufacturing licences and GMP certificates
• Review and compare revised SmPCs, clinical labels, manufacturing licences, GMP certificates and related documents
• Provide CMC regulatory expertise and support targeted authoring, updating or expert review of sIMPD and other CMC documentation
• Coordinate regulatory change-control activities, including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems
• Provide regulatory intelligence and practical interpretation of EU/EEA requirements
• Collaborate with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams
• Identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines
• Support development and continuous improvement of processes, templates, trackers, decision frameworks and ways of working
• Ensure activities and deliverables meet applicable regulatory, quality and organizational requirements

Compliance jobs in Switzerland

Compliance Specialist

Regulatory Affairs Manager

Regulatory Affairs Manager/Senior Manager – CMC, Regulatory Change Management