European Medicines Agency

Project Manager

• passionate about transforming complex regulatory environments through data, digital innovation, and evidence driven process optimisation
• lead strategic initiatives that will shape the future of how medicinal products are regulated and managed across Europe
• responsible for planning, coordinating, and delivering end-to-end digital transformation projects—from initial concept through to final implementation
• ensure projects meet their defined scope, quality, budget, benefits, and timelines
• drive the digital transformation in regulatory processes at the Agency
• optimise end-to-end workflows, elevate regulatory data quality, and champion the adoption of cutting-edge digital platforms
• collaborate with scientific leads, process owners/leads, IT teams, Industry, European Commission (EC) and National Competent Authorities (NCAs)
• manage progress, adapt to changes in scope/schedule/costs/benefits, and apply Agile, LEAN, or other methodologies tailored to workstreams

Regulatory & Scientific Digitalisation Project Management Specialist

Attorney

• Provide continuous legal support including monitoring, updating and following-up on internal processes
• Ensure compliance with legal, administrative and data protection rules and principles
• Collaborate and coordinate with different departments within the Division and with external and internal stakeholders
• Support the preparation and drafting of compliance documentation
• Provide guidance and training to internal stakeholders
• Contribute to the implementation of the data protection 'by design and by default principle'
• Assist in the compliance assessment of new technologies, e.g. AI, Advanced Analytics tools

Regulatory & Scientific Digitalisation Project Management Specialist

Legal and Compliance Officer