Trainee-Streamlining non-clinical requirements for severe debilitating and life-threatening diseases

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: Streamlining non-clinical requirements for severe debilitating and life-threatening diseases

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

This traineeship will offer the successful candidate the opportunity to strengthen knowledge and expertise in non-clinical development and the 3Rs (Replacement, Reduction, Refinement) at EMA, and to interact with the Non-Clinical Working Party (NcWP), the 3Rs Working Party and the EU regulatory network.

The trainee will evaluate the needs for non-clinical development for severely debilitating and life-threatening diseases (SDLT). This will involve collecting data from marketing authorisation applications and scientific advice procedures to gather necessary information.

The succesful candidate will also review recently published guidelines and recommendation papers for opportunities to streamline programs for SDLT.

The trainee will present the findings of the research at EMA and deliver a report analysing regulatory trends and precedents emerging from EMA procedures on non-clinical development programmes, with the aim of informing the NcWP drafting group preparing a reflection paper on SDLTs.

Learning outcomes

The trainee is expected to:

• Gain an in-depth understanding of the European Medicines Agency’s (EMA) approach to assessment of the non-clinical dossier submitted by pharmaceutical companies when they seek marketing authorisation for their medicinal products.
• Gain an understanding of the EMA's scientific advice procedures and how EMA experts advise applicants on critical aspects of a non-clinical devlopment development program.
• Become familiar with regulatory requirements, agency processes, and regulatory practices related to medicinal products.

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 and communication skills.
• Good understanding of Non-Clinical Pharmacology and Toxicology.
• Understanding of, and/or experience in, the 3Rs (Replacement, Reduction, Refinement) is 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)