Trainee (Implementation and impact analysis of the new Variation Classification Guidelines)

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: Implementation and impact analysis of the new Variation Classification Guidelines

Placement description

We are looking for a trainee in the Procedures Service.

Specific objectives and projects

With the entry into force of the new Variation classification guidelines in Jan 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 variation classification and perform an analysis on the impact of the Variation classification guideline on the number and quality of submissions.

Tasks:

• Review existing guidance and propose the necessary updates to align with the new Variation classification guideline
• 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 Industry/EMA staff on the new Variation classification guideline
• Conduct an analysis on the impact of the new Variations classification guidelines in the submission of minor variations (adherence to the new rules, main issues detected) during 2026 and propose improvement measures if needed (updated guidance, training materials...)

Learning outcomes

• 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 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

Ability to compile, summarise and present information clearly and effectively; strong analytical and organisational skills; good project management skills; ability to work comfortably with IT systems; proactive and collaborative approach.

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 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