Job Description
Role Overview:
The Global Project Manager (GPM) is responsible for planning, coordinating, and tracking global biosimilars development projects from early development through regulatory submission and lifecycle management. The role ensures cross-functional alignment, timely execution, and adherence to scope, budget, quality, and regulatory requirements under the guidance of senior leadership.
Specific responsibilities:
- Support global biosimilars development projects across functions (CMC, Nonclinical, Clinical, Regulatory, Quality, Supply Chain).
- Develop and maintain integrated project plans, timelines, milestones, and deliverables.
- Track project progress, risks, issues, and dependencies; escalate as appropriate.
- Organize and facilitate global project team meetings, governance forums, and documentation.
- Ensure compliance with global regulatory requirements (EMA, FDA, WHO, ICH).