GRA CMC Specialist — CSL Behring

Position Purpose Partnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements. Supporting digital innovation, enabling capital project initiatives, and managing strategic external partnerships by coordinating and aligning regulatory CMC strategies and activities across the enterprise. Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives. Main • Responsibilities and Accountabilities Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions. Assess and facilitate the use of digital innovation for Global Regulatory Affairs CMC, including AI/ML applications that manage or support regulatory submission, notification, assessment and intelligence activities. Collaborate with Procurement, IT, external vendors, and R&D Global Regulatory Affairs to implement next-generation solutions that enhance the generation of regulatory strategies and execution of regulatory operations. Define and monitor KPIs to measure impact of digital initiatives on operational efficiency indicators. Manage relationships with outsourcing vendors to support global regulatory CMC activities. Serve as contact for external partners, coordinating deliverables, timelines, and compliance across multiple projects and geographies. Mon