Trainee (Implementation and impact analysis of the new Variation Regulation)

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 Committees and Quality Assurance Department.

Specific objectives and projects

With the entry into force of the new Variation Regulation in Jan 2025 and the Variation classification guideline that is expected to come into force in Q1 2026, a series of tasks are required to ensure a smooth transition for both Industry and regulators. The trainee will participate in the analysis and update of the external guidance to applicants on variations and perform an analysis on the implementation of the Variation Regulation for type IA variations and Worksharing procedures.

Tasks:
- Review existing guidance and propose the necessary updates to align with the future Variation classification guidance
- Participate in the discussions with the different stakeholders (EMA, CMDh, Working parties) on the update of the EMA external guidance
- Support the preparation of training materials and training sessions to assessors/Industry/EMA staff on the new Variation classification guidance
- Conduct an analysis on the impact of the new Variations Regulation in the submission of IA variations and Work sharing (adherence to the new rules, main issues detected, level of compliance) during 2025 and propose improvement measures if needed (updated guidance, training materials...)

Learning outcomes

Through this work, the trainee will:
- gain insight in the regulation and existing guidance for variations
- become familiar with agency processes and regulatory practices related to variations
- develop skills in data analysis, communication and change management
- gain insight into training needs for assessors and Industry stakeholders in the context of variations and how to develop training materials

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

Good analytical and organizational skills.
Good writing communication skills with ability to compile, summarize and present information clearly and effectively.

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.