Trainee (Labeling and naming policy)

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 Human Medicines Division.

Specific objectives and projects

As a trainee in the Labeling office you will be involved in the following projects:

1. Name safety: conduct a thorough analysis of medication error reports related to product names, and identify potential trends and limitations to inform new regulatory policies.
2. Robotic process automation (RPA): support the launch of our innovative RPA tool designed for the validation of name applications, analyse failure scenarios that require manual intervention and propose solutions.
3. Digitalisation: evaluate the outcomes of a pilot project with the National Competent Authorities, identify additional needs or limitations before scaling up the project, and collaborate with our digital team to enhance regulatory digitalisation efforts.
4. Regulatory process improvement: perform comprehensive mapping of regulatory processes in preparation for revamping our name review database, contribute to streamlining and improving regulatory workflows.

Learning outcomes

By the end of this traineeship, you will walk away with practical skills and experiences that will set you apart as you launch your career. In particular, you will:
- increase your knowledge of the EMA activities and its network.
- acquire in-depth regulatory knowledge and experience in the area of naming, product information and prevention of medication errors through labelling elements.
- gain insights into the impact of name safety on public health.
- acquire hands-on experience with the use of novel technologies and digital means in core regulatory processes.
- be at the forefront of automation in regulatory processes.
- build confidence working with a diverse team.

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 Pharmacy, Medicine or Life Sciences (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 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

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

Additional skills

•    Basic knowledge of the European pharmaceutical legal framework.
•    Experience in process or project management desirable.

A post-graduate certification or experience in regulatory affairs would be an advantage.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

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

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) 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 €1,942.19 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.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.