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, ...