Trainee (Analysis of the New Pharmaceutical Legislation's impact on process documentation)

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Traineeship in the Process Management Office (Human Medicines Division)

About this traineeship

EMA is looking for two trainees in the Process Management Office.

About the traineeship programme

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme, or PhD students or Master's students (who possess a previous degree), who are interested in gaining experience and contributing to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

In December 2025, an agreement was reached on an ambitious reform of the current EU Pharmaceutical legislation aiming to make the EU pharmaceutical framework more competitive: the New Pharmaceutical Legislation (NPL). Before the NPL becomes fully applicable, many processes managed by the Agency will need to be adapted during the transition period, particularly within the Human Medicines Division, which runs processes related to the lifecycle of human medicines, including scientific advice, marketing authorisation applications and variations.

In this context, the Process Management Office supports the implementation of process changes affecting the Human Medicines Division and is looking for two enthusiastic trainees to contribute to this project by analysing the gap between current internal and external process documentation, guidelines and information, and the requirements of the NPL, with the aim of drafting proposals for optimisation.

Project description

The project focuses on conducting a research-driven analysis and optimisation of current process documentation in line with the New EU Pharmaceutical Legislation reform. It also aims to ensure consistency, accessibility and alignment between internal guidelines for Agency staff and external information disseminated to industry stakeholders and National Competent Authorities (NCAs) through the Agency's websites, guidelines and communication channels.

The trainees will develop recommendations and practical tools to improve documentation and communication processes. This will support the Agency's implementation of the legislation while enhancing transparency and efficiency for stakeholders.

Trainee activities

• Analyse the implications of the New EU Pharmaceutical Legislation for documentation requirements and propose improvements, including templates, visual aids or digital optimisation solutions.
• Conduct research on best practices in regulatory documentation management, stakeholder communication strategies and knowledge-sharing approaches used by other EU regulatory bodies.
• Perform mapping and gap analysis of existing internal process documentation versus public-facing information on websites and guidelines, identifying inconsistencies, redundancies and opportunities for optimisation.
• Investigate stakeholder needs (e.g. through review of feedback, surveys or literature) regarding documentation clarity and accessibility for industry and NCAs.
• Collaborate on the development of an optimised documentation framework and communication processes, including pilot testing of updates where appropriate.

Expected outputs

• Proposed optimised documentation framework, including templates, guidelines and recommendations for alignment between internal and external resources.
• A set of prioritised improvement proposals with an implementation roadmap presented to the team.
• Drafting materials such as updated website content or training overviews for internal use.

Learning outcomes

Trainees will gain valuable hands-on exposure to EU pharmaceutical regulatory processes, the implementation of major legislative reforms and multi-stakeholder communication in a public-health context. They will develop skills in research methodology, process analysis, documentation optimisation, regulatory writing, and cross-functional collaboration; all highly relevant for careers in regulatory affairs, health policy, or knowledge management.

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway.
2. Possess a scientific degree in phamacy/chemistry or any other life science (minimum of three years or more) that must have been obtained between 6 May 2025 and 6 May 2026, or be a university student on an Erasmus+ or a similar programme, or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
3. Have a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages.

Additional skills

Experience in regulatory affairs and/or quality assurance.

Behavioural competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2026 – 31 July 2027) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

What EMA offers

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)

Job segment Pharmaceutical, Compliance, Regulatory Affairs, Quality Assurance, Law, Science, Legal, Technology