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

compliance

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

• Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging appropriate business insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
• Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners.
• Supporting, potentially leading, health authority interactions in stationed country (FDA or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities.
• Engaging GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed.
• Within GRAST, effectively foster two-communication between GRAST and R&D teams ( e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globally.

Manager, Regional Regulatory Lead – US, Vaccines

Senior Manager Regional Regulatory Lead at CSL Behring developing global regulatory strategies for vaccines. Leading interactions with FDA and EMA and ensuring timely regulatory outcomes.

director

• Ensure that the people, processes, and systems across R&D are fully prepared for digital transformation.
• Drive agile delivery, change management, and process design for digital solutions.
• Lead business analysis to align projects with R&D priorities.
• Oversee agile delivery frameworks and support scrum teams.
• Monitor value realization and build metrics frameworks for assessment.
• Collaborate with R&D stakeholders for continuous improvement.

Senior Director, R&D Digital Enablement Lead

R&D Digital Enablement Lead ensuring readiness for digital transformation in scientific organization. Driving agile delivery and change management to realize digital solutions' value.

• Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams
• Manage platform implementations, updates, and optimization of system solutions for regulatory document management, registration tracking, compliance management, submission, publishing, and safety case processing
• Oversee the setup, integration, and ongoing governance of PV and regulatory platforms
• Own and manage the PV and regulatory platform roadmap
• Build and maintain strong relationships with regulatory and PV business stakeholders
• Drive process improvements and ensure alignment with business and regulatory needs
• Partner with the R&D and Enterprise Data, Automation and AI teams to advance digital capabilities

Senior Director, PV & Regulatory Platform Lead

Acts as operational interface for pharmacovigilance and regulatory affairs teams at CSL Behring. Manages platform implementation and optimizes regulatory processes in compliance with global standards.

• Provide global oversight, leadership and direction to develop and execute global regulatory ad/promo strategies
• Participate in the review and approval process for promotional and non-promotional materials
• Serve as the primary point of contact with regulatory bodies
• Partner with Legal, Compliance, Medical, and Commercial teams
• Lead the development and implementation of global policies, SOPs, and training programs
• Build and manage a high-performing global ad/promo team
• Identify and mitigate regulatory risks in promotional materials and campaigns
• Support the integration of digital and emerging media in advertising strategies

Director, Global Advertising – Promotion

Director of Global Advertising and Promotion overseeing global regulatory strategies and compliance at CSL Behring. Leading cross-functional teams in dynamic biotech ecosystems for innovative therapies.

financial-planning-and-analysis

• Reporting to the Executive Director, Enabling Functions Finance & Finance Innovation.
• Lead the Finance Business Partnering support for the HR and CEA functions.
• Partner with the business in achieving their strategic goals by providing financial guidance.
• Manage costs, evaluate initiatives, identify opportunities and manage risks.
• Deliver agreed KPIs and reporting to the HR & CEA leaders.

Director, Finance Business Partner, HR – CEA

Director of Finance Business Partnering for HR & CEA at CSL Seqirus in a hybrid role. Leading financial analysis and supporting strategic goals for the HR and CEA functions.

project-manager

• Lead the successful operational delivery of global, cross functional R&D projects of strategic importance to CSL's product portfolio
• Work closely with project leader to define strategy and operational tactics
• Prepare and manage project budgets, sensitivities, resources, project timelines, project scope and all other project documentation
• Accountable for the accuracy and quality of reports to senior stakeholders
• Lead cross functional development teams through tactical execution of project plans
• Identify, manage and resolve project issues and mitigate risks
• Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current
• Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans
• Monitor performance vs. plan (budget and timeline)
• Coordinate program updates to Sr. Management
• Provide coaching and mentorship to more junior members of the R&D Global Project Management Department
• Report to the Executive Director Head Regulatory

Associate Director, Project Manager

Lead operational delivery of global cross-functional R&D projects at CSL Behring, overseeing budgets, timelines, risk mitigation and senior stakeholder reporting.

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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