GRA CMC Specialist

Team Lead, Global Regulatory Affairs x 2 The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for: Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products. Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. 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.   Reporting relationships Role that this position reports to: Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products Role/s that report to this position: N/a Main Responsibilities and Accountabilities Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions. Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals. Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements. Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its biological & non-biol. product portfolio. Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management. Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business…