Sobi - Swedish Orphan Biovitrum AB (publ)

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

Role Description Join Sobi’s Global CMC Science & Technology team and help shape how our medicines are developed and supplied worldwide. We’re hiring an Analytical Science & Technology (Analytics) Expert who will take a leading analytical role across our project and product portfolio. Working cross-functionally with colleagues throughout Sobi—and in close partnership with external contract manufacturing organizations (CMOs) globally—you’ll ensure our analytical methods remain compliant, robust, and fit for purpose, while also driving method transfers, validations, and continuous improvements. You’ll coordinate stability studies and support investigations and quality activities (deviations, changes, and CAPAs), acting as an Analytical Subject Matter Expert (SME) to help deliver reliable products to patients. This is a remote role located within the European time zone, reporting to Group Head Analytics based in Sobi HQ, Stockholm. Key Responsibilities - Act as Analytics SME taking overall responsibility for analytical methods and analytical related work for the specific product in e.g. the virtual plant teams. - Responsible for analytical method transfers, validations as well as supporting product stability and shelf life through ongoing stability studies. - Establishment and maintenance of reference materials and responsibility for product specific method standards and qualified materials (critical reagents). - Ensure life cycle management, compliance, robustness, and relevance of analytical methods. - Act as SME in work with regulatory filing, new launches as well as the ongoing work with supply of the commercial products. - Support investigations of deviations, changes and CAPAs, complaints, out of trends (OOT) and out of specifications (OOS). Qualifications - MSc/PhD, analytical chemistry/chemistry/biochemistry/pharmacist/chemical engineering or similar. - +5 years of experience in Life Science/Pharma industry with commercial products. - Experience of analysis of biological drugs, validation, analytical tech transfer, stability studies, specifications, handling of reference standards and critical reagents. - Skilled in common QC methods in the laboratory, e.g. any of HPLC, spectroscopy, ELISA, bioassay. - Experience of working with contract manufacturers with CMOs and CLOs. Benefits - Collaborative and team-oriented environment. - Opportunities for professional growth. - Diversity and Inclusion. - Competitive compensation for your work. - Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments. - Emphasis on work/life balance.

• As members of the Health Systems Director team, individuals in this position are responsible for the sales and access strategies that underpin SOBI Rare Disease products in and for achievement of assigned objectives for both the region and assigned institutions/hospitals/health systems • The Health Systems Director (HSD) will be accountable for working cross-functionally to ensure access to therapy for patients in hospitals and other care settings, as per the product label • This includes appropriate management and coordination of supporting SOBI teams to engage with health system stakeholders including C-Suite leaders, P&T committees, Pharmacy Directors, and external experts • Health Systems Directors are accountable for coordinating their own account-based activities alongside those in Market Access, Patient Services, and medical teams who have responsibilities in the same accounts • Strong clinical acumen will be paramount in this role • The HSD is responsible for effectively sharing on-label scientific information that translates into real world practice • The HSD will build strong relationships with key decision makers throughout their accounts and will provide customers with product and disease information that helps them develop and implement protocols for optimal patient care • The Health Systems Director will be responsible for nurturing and channeling advocacy to support patient protocols consistent with the full parameters of the label • The HSD will develop and execute account plans based on the national and regional strategies