Global Project Manager - Biosimilars

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).