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You will be responsible for planning, coordinating, and executing cross-functional projects from product development and technology transfer through to commercial readiness. This role ensures projects are delivered on time, within scope, and in compliance with regulatory and quality requirements while aligning with organisational strategy.
Job Responsibility:
Lead and manage pharmaceutical development projects across formulation, analytical, CMC, clinical supply, and regulatory functions
Develop and maintain detailed project plans, timelines, budgets, and risk registers
Coordinate cross-functional teams including R&D, QA, QC, Regulatory Affairs, manufacturing, and external partners (CROs, CMOs)
Track project milestones, deliverables, and dependencies
proactively identify and mitigate risks
Facilitate project meetings, prepare agendas, document decisions, and communicate progress to stakeholders and leadership
Ensure compliance with GMP, GLP, GCP, and applicable regulatory guidelines (FDA, EMA, ICH)
Manage change control processes and assess impact on scope, timelines, and cost
Support preparation for regulatory submissions, audits, and inspections as needed
Maintain accurate project documentation and reporting dashboards
Promote best practices in project management and continuous improvement within development teams
Requirements:
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific field
PMP, Prince2, or equivalent project management certification
5+ years of project management experience within pharmaceutical or biotechnology development
Experience working with global teams and external vendors
Demonstrated experience managing cross-functional development projects
Strong understanding of drug development lifecycle and CMC processes
Proficiency with project management tools (e.g., MS Project, Smartsheet, Jira, or equivalent)
Excellent communication, organizational, and stakeholder management skills