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.
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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). xpzdshu
PMP or equivalent certification is a plus.