Trainee (Voluntary Data Submission Pilot for New Approach Methodologies)

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.

Trainee (Voluntary Data Submission Pilot for New Approach Methodologies)

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 posses a previous degree), who are interested in gaining experience and contribute 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

We are looking for a trainee in the Translational Sciences Office.

Specific objectives and projects

Context: In recent years, pharmaceutical companies and research organisations have increasingly adopted New Approach Methodologies (NAMs)—such as advanced laboratory-based models, human-relevant complex in vitro systems (e.g. organ-on.chips) and computer-based modelling—to support medicine development. These approaches are driven by scientific innovation, improved human relevance and the aim to reduce reliance on animal testing. As the use of NAMs expands, medicines regulators need to understand how these data are generated, what their strengths and limitations are, and how they can be meaningfully integrated into regulatory assessment frameworks. To respond to this rapid scientific development, the European Medicines Agency (EMA) has launched a Voluntary Data Submission (VDS) pilot project, allowing companies to voluntarily share NAMs data with regulators outside formal marketing authorisation procedures. This pilot supports regulatory learning, dialogue and preparedness for future use of such data. The traineeship will be hosted in the Translational Sciences Office, which supports the integration of innovative methods across the medicine development lifecycle and the 3R (Replacment, reduction and refinement) principles.

Project description and trainee tasks

The trainee will contribute to the VDS pilot project focused on NAMs and their potential role in regulatory science. Working closely with scientific staff and the EU network, the trainee will be involved in activities such as:

• Supporting the coordination of interactions with companies and research organisations participating in the voluntary data submission pilot
• Assisting in the organisation, review and structured summarisation of submitted scientific data packages based on innovative non-animal methods
• Contributing to the preparation of background documents, briefing notes and presentations describing the scope, objectives and outcomes of the pilot project
• Supporting the analysis of lessons learned from the pilot, including scientific, procedural and data-integration aspects
• Participating in internal discussions to gain insight into how regulators explore and prepare for the future use of emerging scientific evidence

Learning outcomes

By the end of the traineeship, the trainee will have:

• Gained a practical understanding of how innovative scientific methods, including New Approach Methodologies (NAMs), are increasingly used by pharmaceutical companies to support medicine development, and how regulators respond to this scientific evolution
• Developed insight into the role of the European Medicines Agency in preparing for the integration of emerging scientific evidence into regulatory assessment frameworks
• Acquired hands-on experience in reviewing, organising and summarising complex scientific data packages, with a focus on innovative non-animal methods and their scientific context of use
• Learned how scientific information is discussed and evaluated in multidisciplinary regulatory settings, involving experts from different scientific backgrounds
• Gained experience in interacting with external stakeholders, such as industry and research organisations, in a structured and transparent regulatory environment
• Developed skills in drafting clear scientific summaries, background documents and presentations aimed at different audiences, including scientists and regulatory decision-makers
• Improved understanding of how lessons learned from pilot projects are translated into internal reflections, future guidance development or regulatory recommendations
• Strengthened transversal skills, including analytical thinking, scientific communication, collaboration and time management, in an international public health organisation

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 university degree in Non-Clinical Pharmacology, Toxicology, Pharmacy, Biomedical Sciences, or any other Life Sciences (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. 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

In addition to the eligibility criteria, you will have:

• analytical skills;
• communication skills;
• good understanding of non-clinical pharmacology, toxicology;
• understanding of and/or experience in 3Rs and the regulatory framework are considered beneficial.

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.

The Agency pays a monthly stipend of €2,049.77 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

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

What do we offer?

• 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)

recruitment@ema.europa.eu