Regulatory & Scientific Digitalisation Project Management Specialist

European Medicines Agency

Project Manager at EMA leading digital transformation in medicine regulation across Europe. Planning, coordinating, and delivering projects with a focus on process optimization and collaboration.

Posted 6/1/2026full-timeAmsterdam • 🇳🇱 NetherlandsMid-LevelSenior💰 €5,979 per monthWebsite

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Applicant Tracking System Keywords

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Hard Skills

project managementdata analyticsAgile methodologyLEAN methodologyprocess mappingtarget-operating-model definitiondigital transformationregulatory data qualityevidence driven process optimisationend-to-end workflows

Soft Skills

collaborationcommunicationadaptabilitystrategic thinkingleadershipplanningcoordinationproblem-solvinguser requirement prioritizationtraining and adoption

Tools & Technologies

digital platformsregulatory systemsproject management softwaredata management toolscommunication toolsAgile toolsLEAN toolsevidence management systemsworkflow management systemsregulatory compliance tools

Industry Keywords

regulatory environmentmedicinal productsEuropean CommissionNational Competent Authoritiesscientific activitiesmedicine evaluationprocess transformationsustainable changebenefit realisationuser requirements

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway
have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2)
have fulfilled any obligations imposed by applicable laws concerning military service
possess a university degree (minimum of three years) that must have been obtained by the closing date of this vacancy notice
at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date of the publication
experience in either project management and/or data analytics
extensive experience within the regulatory/scientific activities relevant to the evaluation and/or monitoring of medicines
experience with major digital/process transformation initiatives, applying Agile or other recognised delivery methodologies with proven ability to embed improved ways of working
experience planning communication, training and adoption to ensure sustainable change and benefit realisation
extensive experience in understanding and prioritising user requirements, process mapping and target-operating-model definition with the ability to translate regulatory/scientific needs into implementable backlog item.

Benefits

Comp & perks

Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
Relocation assistance
Excellent health insurance scheme and social benefits
Retirement Pension Plan