JOB DESCRIPTION

 

About the position:

The revision of the European pharmaceutical legislation is a unique opportunity to reshape medicines regulation in the EU and make the EU regulatory framework more fit for innovative medicines, to promote greater access to medicines for patients and to address the major public health challenges of the future (e.g. antimicrobial resistance).

The new pharmaceutical legislation will simplify structures and procedures which have been introduced by different pieces of legislation over the years. A simplified and more integrated regulatory system will be easier to navigate for developers and aims to make Europe more attractive and competitive in the global environment.

The revised legislation will also reduce administrative burden, to help improve sustainability of the European medicines network, rationalise the use of the scientific assessment resources in the network, and become more agile in dealing with complex medicine assessments.

In this context, EMA is looking for a Change Management Specialist with intra organisational and extra organisational change management capabilities to reinforce the team coordinating the implementation of this legislation.

The Change Management Specialist will be responsible for leading the change management programme to implement the new European pharmaceutical legislation as part of EMA’s implementation team. The change management specialist will create and implement a responsive strategic framework to enable EMA, the European medicines regulatory network, industry and other stakeholders to successfully adopt the transformational changes resulting from the new European pharmaceutical legislation.

Please note, the recruitment procedure for this role may also serve recruitment for other future change manager roles in EMA. This may include roles for change managers to support digital transformation, support implementation work in the Agile Network Portfolio or support for EMA’s Change Management Centre of Expertise.

While we are currently recruiting for this specific role, we are also building a talent pool for other upcoming change management positions at EMA. Future opportunities may include change management roles supporting digital transformation, implementation work in the Agile Network Portfolio, or our Change Management Centre of Expertise. We encourage applications from candidates interested in any of these areas.

Duties and responsibilities of the job holder:

Strategic Leadership & Planning

• Lead development and implementation of the change management strategy and plan to ensure effective adoption of the new pharmaceutical legislation across the EMA, the EU medicines regulatory network, and its stakeholders;
• Assess organisational readiness, identify capability gaps, and develop mitigation strategies to address risks and ensure successful change adoption;
• Design measurement frameworks to track adoption, evaluate progress and guide course corrections to achieve strategic objectives;
• Work across multiple workstreams and collaborate with EMA leadership to align change activities with strategic objectives;
• Integrate change management with project management workstreams and governance, working closely with the programme manager and Head of Human Medicines Division.

Stakeholder & Communication Management

• Map and engage the diverse stakeholder ecosystem across the regulatory network, industry and healthcare and patient groups, to facilitate buy in and adoption;
• Develop and execute strategic communication plans tailored to different audiences in collaboration with the implementation team and in liaison with internal and external communications teams;
• Create collaborative relationships with national competent authorities to ensure coordinated implementation;
• Establish feedback mechanisms to capture stakeholder insights, address resistance and refine change approaches.

Implementation & Capability Building

• Conduct change impact analyses and design tailored transition approaches for critical processes;
• Identify and manage risks to successful change adoption;
• Establish and lead a change agent network spanning key functions at EMA and in national competent authorities;
• Develop and deliver capability building programmes including training and coaching, leveraging relevant experts and leaders, to equip staff and stakeholders for changes.

Continuous Development

• Capture implementation lessons to refine the change management approach and contribute to evolving EMA’s change management methodology;
• Transfer knowledge and skills to build sustainable organisational change capability;
• Ensure ongoing alignment with EU regulatory standards and EMA policies throughout the change process.

Here is the link to the role description outlining generic duties and responsibilities of the Change Management Specialist: Change Management Specialist (CF-07-01-140)

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

General Condition 1 and Specific Conditions 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 also need to have:

Experience

Out of the 3 years of experience listed under Specific Conditions (Eligibility criteria) a minimum of 2 years of experience in regulated industries (pharmaceuticals, medical devices, healthcare strongly preferred) managing business change in complex multi-stakeholder regulated environments.

Skills and Knowledge

• Solid understanding of applying recognised strategic analysis frameworks (e.g. SWOT analysis, value chain analysis) to assess organisational challenges and opportunities;
• Working knowledge of assessing and quantifying the business impact of change initiatives across multiple organisational functions and stakeholders;
• Good understanding of digital transformation concepts and their application to organisational change;
• Basic knowledge of the lifecycle of medicines and the regulation of medicines in the EU or in other highly regulated industries and their multi-stakeholder ecosystems.

Certificates

• Professional certification in change management from a recognised training organisation.

Competencies you will need to have:

Role competencies

• Influencing and persuading, Intermediate
• Stakeholder relations management, Intermediate
• Visionary thinking and strategic planning, Basic
• Understanding business context, Intermediate

Sub-family competencies

• Managing change and transition, Intermediate
• Programme 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.

Nice to have

Education

• Master’s degree in Business Administration, Management, Psychology, Organisational Psychology, Change Management, or related field.

Selection procedure timelines

Please note, timelines may change

Deadline for applications	21 October 2025 23:59 CET
Preliminary Assessments	21 November 2025
Final assessments	Estimated: 2nd and 3rd week of December 2025
Decision expected	3rd week of January 2026

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note:  Candidates who fail any assessment linked to any Need to Have requirement, Sub-family, Grade specific competencies, Role competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA – Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria and Sub-family competences and Role competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA – Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.

Assessments

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

Please consult the Careers at EMA – Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.

Reserve list and/or job offers

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

If Temporary Agent posts are not available, if justified in the interest of the service, candidates on the reserve list may be approached to provide written consent to be considered for Contract Agent positions. . These candidates will remain on the Temporary Agent reserve list and will be considered for a Temporary Agent post should a suitable post become available.

Contract Agent posts differ from Temporary Agent posts in terms of categories, function groups, grades and remuneration and career progression.X

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.