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).
• Coordinate preparation of project reports, dashboards, and development updates.
• Support submission planning activities and change management.
• Foster effective communication across internal teams and external partners (CMOs, CROs).

What are we looking for?

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field (Master’s preferred).
• Languages : Fluent English (spoken and written) is mandatory, as the role operates in a global, cross-functional, and multicultural environment. Additional languages are a strong plus.
• Experience:
• 5-10 years of experience in pharmaceutical or biotechnology development, preferably biosimilars.
• Minimum of 3 years of experience in project management.
• Great understanding of biosimilars development pathways and regulatory expectations.
• Experience working in cross-functional, global project teams.
• Skills:
• Strong organizational, communication, and documentation skills.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Planisware).
• PMP or equivalent certification is a plus.