Regulatory & Scientific Digitalisation Project Management Specialist

About this position:

Are you passionate about transforming complex regulatory environments through data, digital innovation, and evidence driven process optimisation? The European Medicines Agency (EMA) is seeking a dynamic project manager with business analytics experience to lead strategic initiatives that will shape the future of how medicinal products are regulated and managed across Europe.
In this pivotal position, you will be responsible for planning, coordinating, and delivering end-to-end digital transformation projects—from initial concept through to final implementation. You will ensure projects meet their defined scope, quality, budget, benefits, and timelines, while embedding best practices in safety, sustainability, and regulatory excellence.
In this role you will drive the digital transformation in regulatory processes at the Agency, transforming how medicinal products are managed from inception to market. As a key innovator, you will 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) to deliver tangible benefits: enhanced efficiency, superior quality, greater transparency, improve collaboration and advanced knowledge management. This role bridges scientific expertise with business acumen and IT solutions, proposing innovative strategies to eliminate waste, harness data analytics, and treat data as a strategic asset for insightful decision-making—ultimately accelerating safe, effective, quality medicines for patients across Europe. 

Here is the link to the Role Description of Project Management Specialist outlining the generic duties and responsibilities: link to be inserted

In this role you will:

•    Contribute to elevating the Agency's programme management capabilities through methodology development and continuous improvement initiatives;
•    Define project scope and objectives for regulatory-process transformations, engaging scientific area leads, process owners/leads, and IT delivery teams to ensure feasibility, compliance, and alignment with Agency standards—while analysing the value of each process step to maximise efficiency, transparency, and public health outcomes;
•    Report via the Agency's framework; track and measure performance (time, cost, quality, benefits) using KPIs linked to regulatory outcomes, identifying innovation opportunities that enhance stakeholder value and data-driven insights across the medicines lifecycle;
•    Manage progress, adapt to changes in scope/schedule/costs/benefits, and apply Agile, LEAN, or other methodologies tailored to workstreams—e.g., as Project Manager, Epic Owner, or Product Owner in major digital projects—ensuring outputs deliver exceptional quality that meets or exceeds scientific and regulatory excellence standards;
•    Organise and lead multidisciplinary teams (business, data, IT, vendors), providing tools, skills, and motivation for success, while mapping stakeholder needs to tailor solutions that address diverse requirements from NCAs, industry partners, and scientific committees; 
•    Leverage Agency frameworks and LEAN reengineering to simplify/automate workflows, focusing on data quality, waste elimination, process design, analytics, and data-driven insights—evaluating the business value of each regulatory step to eliminate redundancies and amplify strategic assets like predictive analytics for faster approvals. 

In addition, you will also:

•    Elicit requirements through interviews, workshops, and analysis; validate with stakeholders to translate business needs into digital solutions, ensuring high-quality deliverables that reflect a deep understanding of what each stakeholder (e.g., regulators, industry, patients) requires for informed, evidence-based decisions; 
•    Conduct risk management, escalating as needed; coordinate quality compliance, operational readiness, maintenance, and end-user support, prioritising outputs that uphold the highest standards of accuracy, reliability, and relevance in a public regulatory environment; 
•    Handle supplier/contract management: monitor deliverables, participate in tenders, and develop specifications, while assessing vendor contributions against business value metrics to ensure cost-effective, high-quality partnerships that support regulatory goals; 
•    Maintain comprehensive documentation; contribute to audit action items for sustained excellence, incorporating business analysis to demonstrate how process improvements/redesign and digitalisation deliver tangible value, such as improved knowledge management and stakeholder satisfaction.

In particular, a Project Management Specialist will:

• Provide regular project updates to governance bodies and senior stakeholders on strategy, status, benefits, risks and dependencies; prepare briefings for decision‑making; 
• Collaborate and engage with scientific area leads, Process Owners/leads, Change Champions, IRIS implementation stakeholders, IT specialists and NCA experts to align business change and digital platform capabilities; 
• Facilitate Agile/LEAN workshops and requirements elaboration sessions; influence decisions to remove roadblocks and resolve cross functional issues; 
• Manage vendor/supplier communications and expectations, clarifying deliverables, acceptance criteria and timelines; ensure compliance with contract obligations.

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:
General conditions:
1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. 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);
3. have fulfilled any obligations imposed by applicable laws concerning military service.
 

Specific conditions:
1. possess a university degree (minimum of three years), that must have been obtained by the closing date of this vacancy notice 

and

2. at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date of the publication.

General Condition 1 and Specific Conditions 1 and 2  will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure. 
Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will need to have:

Experience

• 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.

Skills & Knowledge

• Managing a project team, including building and coaching teams in higher level of stakeholders’ complexity; 
• A track record of coaching teams in Agile practices, or equivalent, such as Scrum, Kanban, or similar, self-organisation and continuous improvement; 
• Ability to tailor methodology to various context, preferably in  regulatory contexts; 
• Knowledge of Agency scientific/regulatory procedures and cross‑functional stakeholder needs across the medicines lifecycle;
• Ability to bridge regulatory, scientific and IT perspectives; 
• Familiarity with regulatory digital platforms used to manage scientific and regulatory activities and their implications for data quality, transparency and knowledge management; 
• Understanding business value and critical thinking for innovative solution; 
• Excellent communication skills for stakeholder influence; 
• Ability to understand and connect data to support data driven decision.

Competencies you will need to have:

Sub-family competencies     

• Managing change and transition - Intermediate
• Program and project management - Intermediate
• Applied knowledge - Intermediate

Grade competencies      

• Adaptability and agility - Intermediate
• Analysing and problem solving - Intermediate
• Prioritising and organising - Intermediate

Core competencies      

• Ethics and Integrity - Intermediate
• Team collaboration - Intermediate
• Customer centricity - Intermediate
• Results orientation - Intermediate
• Communication    Intermediate
• Cross-cultural sensitivity - Intermediate
• Continuous learning and self-development - Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Experience

• Experience contributing to the implementation of customer relationship management systems for regulatory information management (such as the IRIS implementation at EMA) or similar digitalisation projects focused on regulatory/scientific workflows;
• Experience collaborating with National Competent Authorities experts and multi‑stakeholder steering groups on cross‑EU regulatory initiatives.

Skills & Knowledge

• Knowledge of project management tools like Microsoft Project and / or Agile planning tools;
• Understanding of EMA structures, core processes and stakeholders landscape. 

Certificates

• Certified PRINCE2 and/or SAFe Agile;
• Green Lean Six-Sigma belt or superior.