CSL Benefits Overview

Leads global regulatory affairs activities, securing permits, licenses, certificates, authorizations, and approvals for business operations and product distribution. Advises management on regulatory developments, manages regulatory plans and documentation, maintains regulatory systems, and represents the organization before government and industry authorities. Requires pharmaceutical regulatory experience, with biologics experience preferred.

Leads project management for biotech due diligence and external innovation activities, including in-licensing and partnership evaluations. Develops integrated plans, timelines, budgets, risk tracking, governance tools, dashboards, and decision-support materials. Coordinates scientific, clinical, regulatory, legal, IP, commercial, and finance stakeholders; ensures timely, compliant evaluations; supports senior leadership decisions; and improves due diligence workflows and tools. The role also mentors junior team members and manages relationships with external partners.

Lead epidemiology strategy and programs for assigned products, design and execute studies, manage data and vendors, contribute to regulatory submissions, drive RWE use, perform benefit-risk assessments, and support departmental process improvement and cross-functional leadership.