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• Support complex and higher exposure quality and compliance activities
• Provide guidance and risk assessment on GCP, GVP, MDR, and IVDR compliance issues
• Serve as advisor and subject matter expert for Quality and Compliance-related processes
• Lead deviation management and process management activities

• Define early disclosure strategies at study concept and protocol stages as well as during amendment stages
• Prepare, review, and submit clinical trial registrations across global registries such as CTIS and ClinicalTrials.gov

Define and lead Ypsomed’s global regulatory strategy for drug–device combination products and medical devices, ensuring alignment with business goals and innovation roadmaps...

• Analyze customer pharmacovigilance processes, requirements, and challenges, and provide recommendations aligned with industry best practices and regulatory requirements
• Support the implementation, configuration, validation, and adoption of drug safety solutions

• Support GxP compliance of all activities in the clinical trial supply management, drug-related distribution and storage
• Responsibility for the project-related GxP documentation and maintenance of lists