Director, Sr. Global Regulatory Lead - Cardiorenal

Job description

Position Purpose: The Director, Senior Global Regulatory Lead (Sr. GRL) in Global Regulatory Strategy (GRS) is a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as follows: - Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities. - Acts as a key member and single GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice. - Leads health authority interactions (FDA, EMA) and builds productive relationships to drive positive regulatory outcomes globally. - Engages GRAST members to deliver regulatory outputs, fosters accountability and collaboration, and serves as decision-maker/approver for regulatory deliverables. Ensures strong communication between regulatory and R&D teams. - For selected roles, manages Regional Regulatory Leads and supp...