Global Project Manager - Biosimilars (Madrid)

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; elevate as appropriate.
• Organize and facilitate integral project team meetings, governance forums, and documentation.
• Ensure compliance with global regulatory requirements (EMA, FDA, WHO, ICH).
• Coordinate preparation of pro...