CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology.
Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.
Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
See our community guidelines: https://bit.ly/3Bs17Ra

general-counsel

CSL is a global leader in biotherapeutics and vaccines, focused on the needs of patients with serious and rare diseases. The company comprises CSL Behring, which develops and delivers treatments for conditions like immunodeficiency, hereditary bleeding disorders, and Alpha 1 Antitrypsin Deficiency; CSL Seqirus, a major provider of influenza vaccines; and CSL Vifor, which specializes in iron deficiency and nephrology. CSL operates an extensive R&D network focused on plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, CSL serves patients in over 100 countries with a commitment to innovation and sustainable practices in biotechnology.

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

See our community guidelines: https://bit.ly/3Bs17Ra

• Serve as the primary legal advisor for employment law matters across EMEA, with a focus on Germany and Switzerland.
• Provide strategic counsel on organizational change initiatives, including restructurings and workforce planning.
• Lead negotiations with works councils and manage complex employment-related projects.
• Oversee litigation and manage external counsel, ensuring cost-effective and high-quality outcomes.
• Advise on HR policies, compliance, and internal investigations.
• Deliver training sessions to HR and business leaders on key employment law topics.

Senior Counsel, EMEA Employment Law

Senior Employment Counsel serving as primary legal advisor for employment law in EMEA, focusing on Germany and Switzerland. Overseeing compliance, litigation, and HR policy advisement.

director

• Develop and implement risk mitigation strategies for early development assets (e.g., FIH/Phase 1 studies), ensuring endorsement by CSL Safety Governance
• Review and interpret emerging safety data from preclinical and early clinical studies; contribute to aggregate safety data analysis and key safety documents (DSURs, risk management plans)
• Support the setup and evaluation of preclinical data packages, identify new risks, and determine needs for supplementary data
• Respond promptly and concisely to regulatory agency safety requests
• Ensure risk mitigations are reflected in clinical trial documents (protocols, investigator brochures, informed consent forms)
• Provide guidance on safety issues and facilitate internal/external safety reviews (e.g., DMCs)
• Represent GSPV in cross-functional teams and chair safety management teams as needed.

Associate Director, Early Development Lead, Medical Safety

Associate Director leading medical safety and risk strategies in early development at CSL Behring. Focused on patient safety and cross-functional collaboration in clinical trials.

medical-billing-and-coding

• Ensure implementation of GVP compliant PV standards, processes by the Pharmacovigilance Scientists, Device expert, and Medical coding expert under their management and conducts cross-functional collaboration with relevant individuals within PV as well as with key stakeholders
• PVS support for products in the post-marketing phase, as well as those products with ongoing clinical development as required
• Collaboration with Signal Management/Governance/Literature and Aggregate Reports/Risk Management Heads to support the work of PVS within the team, specifically in the contribution to signal detection and assessment activities through the full governance process, literature screening, and key contributions to aggregate reports, risk management plans, and other PVS-assigned responsibilities
• Utilization of managed service partners, ensuring on-time delivery of high-quality outputs assigned with implementation of meaningful KPI measures and regular reporting to senior management will be required
• Creating and implementing a vision which incorporates new technologies and innovative approaches will be essential to lead the team, while ensuring consistent support of the product-responsible GSLs.

Lead Post Marketing, Medical Coding, Device Safety PV Scientist

Lead PV Scientists for lifecycle safety and risk management activities at CSL. Drive innovation in dynamic biotech ecosystems while ensuring safety management for products with existing marketing authorizations.

• Oversee the end-to-end management of the R&D digital portfolio, including project prioritization, resource allocation, and performance tracking to ensure timely delivery and alignment with organizational goals
• Collaborate with cross-functional teams, including R&D, IT, and data science, to ensure that digital initiatives align with strategic R&D goals and objectives
• Develop and maintain portfolio dashboards, KPIs, and reporting mechanisms to keep senior leadership informed of progress and performance
• Facilitate governance processes, including steering committees and investment reviews, ensuring clear decision-making and alignment on digital investments
• Identify risks, dependencies, and opportunities across the portfolio, and recommend mitigation strategies to ensure smooth execution of digital initiatives
• Support the R&D Digital Strategy and Delivery Lead in translating the strategic vision into executable programs, ensuring alignment with the overall digital roadmap
• Ensure consistent use of project management methodologies and tools (e.g., Agile, Waterfall) across all digital initiatives to standardize and optimize project execution

Associate Director, Digital Portfolio – Technology Enabled Science

Associate Director overseeing the digital portfolio within R&D at CSL Behring. Collaborating with teams to drive innovation and strategic alignment across digital initiatives.

manager

• Strategy (execution) & (partner) management. Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly; conduct risk assessments of partners to identify potential risks and vulnerabilities.
• Manage inventory of partners and ensure synergies are identified and implemented.
• Conduct periodic assessments and audits of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities.
• Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions.
• Act as point of contact for escalations and issue resolution related to partner activities.
• Align closely with GRA for contract management purposes to ensure regulatory standards are met.
• Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations.
• Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs.
• Act as primary RA representative for local ComOps: adopt a business perspective and explores opportunities, Translates this thinking into actionable plans that fit with strategy.
• Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track. (Internal) stakeholder management and trainings.
• Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs.
• Stay in close alignment with respective Head Partner Business to oversee partner-specific activities for ensuring timely and standardized delivery of goods and services.
• Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.
• Stay accountable for planning, leading and delivering complex regional strategies across broad range of CSL products, while ensuring alignment with company/commercial strategies.

Manager RPR, GLAD & LATAM

Manager overseeing regulatory partner activities in Latin America for CSL Behring. Focus on compliance, partner management, and regional strategy execution.

• Oversee follow-up activities to ensure that follow-up of cases is done in accordance with the procedural documents.
• Oversee the assessment and the handling of literature articles identified by the Global Literature Office and local literature articles identified by the Safety Officers.
• Serve as case processing Subject Matter Expert (SME) for the input into procedural documents for case processing-related processes (e.g. SOPs, GDLs, work instructions); SME for incorporating process changes into the training material for case processing and for reviewing it for accuracy.
• Collaborate with GSPV and external stakeholders to improve/ optimize case management processes including the development of SOPs and WIs in collaboration with other functions.
• Maintain the tracking tool where new process decisions are tracked and ensuring that users are informed.
• Supporting the investigation / assessment of ICSR compliance activities where required Reg Intelligence (RING) assessment to decide on relevant updates or the impact on case processing due to regulatory updates.
• Audit and inspection readiness including corrective & preventive action (CAPA) management.
• SME for the initiatives or projects in the context of case processing.

Senior Case Processing Oversight Manager

Senior Case Processing Oversight Manager overseeing global regulatory updates and case handling processes at CSL Behring. Collaborating with cross-functional teams to ensure compliance and optimize case management operations.

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

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