Trainee (Pharmaceutical Manufacturing and Inspections under the New EU Legislation)

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: Pharmaceutical Manufacturing and Inspections under the New EU Legislation

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.

Placement description

This traineeship placement is in the Inspections Office at the European Medicines Agency (EMA).

Specific objectives and projects

Context

The EU has launched the most profound and ambitious revision of pharmaceutical legislation in the last 20 years. The Agency, together with the EU regulatory network, is preparing to implement new requirements concerning manufacturing, such as decentralised manufacturing, the Joint Audit Programme (JAP) for Good Distribution Practice (GDP), and enhanced oversight of medicines manufacturing.

Project tasks

• Contribute to the development of new processes and procedures related to the implementation of the new pharmaceutical framework in the area of manufacturing and inspections.
• Contribute to activities related to the implementation of new regulatory requirements and associated change management processes.
• Participate in discussions with inspectors, assessors and other stakeholders within the EU regulatory network.
• Contribute to the preparation of briefing documents and presentations related to the implementation of the new legislation.

Learning outcomes

• Develop knowledge of the regulatory framework for pharmaceutical manufacturing and inspections, as well as EU regulatory network processes.
• Gain experience working on multidisciplinary regulatory projects.
• Gain insight into how EMA collaborates with the EU regulatory network and stakeholders in the context of manufacturing and inspections.

Eligibility criteria

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. Have 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

• Analytical skills.
• Communication skills.
• Project management/organisational skills.

Behavioural competencies

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

What 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)