Global Project Manager - Biosimilars
hace 20 horas
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; 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.