Senior Scientific Specialist (GMP) - European Medicines Agency (Amsterdam)

About this position

The summary below is published by European Medicines Agency on the official vacancy notice. Our own analysis — salary realism, comparable openings, career trajectory, language profile — follows further down the page.

Key responsibilities

According to the vacancy notice, the role centres on the following duties:

• Provide scientific specialist expertise, coordination and regulatory support to the review of manufacturing aspects for human and veterinary medicines and their supply chains across the life-cycle of the medicinal produ…
• Coordinate pre-approval and post-approval GMP and Plasma Master File (PMF) inspections
• Coordinate assessment of quality defects, recalls, and notifications of GMP non compliance
• Contribute/coordinate to scientific and regulatory guideline development in the area of manufacturing
• Support collaboration with other regulatory working parties within the EU and international cooperation on manufacturing and inspection related topics
• Present inspection topics at internal and external fora, acting as an ambassador for the Inspections Office

Are you eligible?

Check these requirements from the notice before investing time in an application:

• Education: University degree (minimum 4 years) in Life Science or General Sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) OR university degree (minimum 3 years) in Life Science or General Sciences
• Experience: At least 9 years' relevant professional experience after obtaining a 4-year degree OR at least 10 years' relevant professional experience after obtaining a 3-year degree, in the field of Life Science or General Sciences. Out of these years, at least 5 years of experience in manufacturing/GMP from work in manufacturing of medicinal products, quality control, quality assurance, innovative manufactu…
• Languages: English (C1), Another official language of the Europe… (B2)
• Key skills: Critical review and drafting of scientific and regulatory documents for expert and lay audiences, Proficient in the use of modern IT systems, ability to work with, analyse and draw conclusions from large sets of data, Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role, Presenting scientific or regulatory matters at a high level
• Eligibility: Must enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway. Must have fulfilled any obligations imposed by applicable laws concerning military service.

Selection process

The notice describes the following selection steps:

• Application form assessment based on general and specific eligibility conditions
• Documentary evidence verification at interview stage
• Selection Committee assessment of eligible candidates
• Competency assessment

Contract and working arrangements

Contract duration: Temporary agent.

Hiring unit: EMA Inspections' Office, Good Manufacturing Practice (GMP) workstream.

Position overview

This is the official EU Careers listing for Senior Scientific Specialist (GMP) at EMA based in Amsterdam (Temporary Agent).

Type of position:Temporary agent

Job Type:22 November 2026 at 23:59 CET

Job grade: AD 8

Internal job grade and Interagency: AD06 and above

Type of position: Temporary agent

Selection procedure reference: EMA/AD/11636

Job title: Senior Scientific Specialist (GMP)

Talent Pool:AD08 Science & Regulation

Deadline for applications: 22 November 2026 at 23:59 CET

Salary: 9577,39 Euro(including local weighting)-1163/1451821633/#_ftn1)plusbenefits(see calculators on the right) (based on a fulltime contract (40hrs/week))

Location:Amsterdam, Netherlands (relocation to take up duties is mandatory)

XX

Role summary

Located in the Good Manufacturing Practice (GMP) workstream of the EMA Inspections’ Office, this role is at the forefront of helping to ensure medicines are manufactured in compliance with GMP standards, while supporting access to innovative therapies for patients and animals.

The role involves contributing to strategic initiatives such as GMP guideline development, technical advice relating to the implementation of legislation, inspection coordination, quality defect and non-compliance assessments and GMP input to marketing authorisation activities. The role also involves supporting the Good Manufacturing and Distribution Practice (GMDP) Inspectors’ Working Group (IWG), representing inspection topics internally and externally and international collaboration.

We are seeking a motivated professional with strong GMP expertise, a broad understanding of the product lifecycle, and the ability to balance technical knowledge with strategic thinking. The ideal candidate will have strong communication and organisation skills, the ability to work both autonomously and in a team, can drive topics forward, ensuring the views of stakeholders are heard, while also contributing their own expertise.

You will work alongside leading GMP and regulatory experts within the EMA Inspections Office, a team of over 30 compliance professionals across GxP disciplines. We offer a collaborative, professional, and forward-looking working environment.

In this role you will:

- Provide scientific specialist expertise, coordination and regulatory support to the review of manufacturing aspects for human and veterinary medicines and their supply chains across the life-cycle of the medicinal product (e.g. evaluation of marketing authorisations and post-authorisation variations and line extensions and scientific advice). - Coordinate of pre-approval and post-approval GMP and Plasma Master File (PMF) inspections - Coordinate of assessment of quality defects, recalls, and notifications of GMP non compliance, within EMA and within the EU regulatory Network and with international partners when required. - Contribute/coordinate to scientific and regulatory guideline development in the area of manufacturing, including providing scientific and regulatory input to the GMDP Inspectors’ Working Group, supporting the building of consensus among members of guideline drafting groups, contributing to the implementation of new legislation and guidelines, whilst keeping overall objectives to protect patient and animal safety in mind. - Support collaboration with other regulatory working parties within the EU (e.g. Quality Working Party/Biologics Working Party) and international co-operation on manufacturing and inspection related topics, including the exchange of compliance information with international partners, and promoting inspection reliance. - Present inspection topics at internal and external fora (e.g. to EMA management, to the GMDP IWG, and at external conferences), acting as an ambassador for the Inspections Office.

Here is the link to the Role Description of Senior Scientific Specialist outlining generic duties and responsibilities:

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions: 1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway; 2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2); 3. have fulfilled any obligations imposed by applicable laws concerning military service.

X Specific conditions:

1. possess a university degree (minimum of four years) in the field of Life Science or General Sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

or

2. possess a university degree ( minimum of three years) in the field of Life Science or General Sciences (e.g. biology, chemistry, biochemistry, pharmacy, engineering) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.

X

General Condition 1 and Specific Conditions 1 and 2will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only eligible candidates will be assessed by the Selection Committee.

You will also need to have:

Experience

- Out of the years of professional experience required above, at least 5 years of experience of relevance to manufacturing/GMP. This experience could be gained from work in the areas of manufacturing of medicinal products for human or veterinary use, quality control, quality assurance, innovative manufacturing and/or GMP inspections/audits, in either pharmaceutical industry or competent authority in the field of medicines regulation.

Skills & Knowledge

- Critical review and drafting of scientific and regulatory documents for expert and lay audiences; - Proficient in the use of modern IT systems, and has the ability to work with, analyse and draw conclusions from large sets of data; - Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role; - Presenting scientific, or regulatory matters at a high level (eg to experts).

Competencies you will need to have:

Role competencies

Influencing and persuading - Advanced

Prioritising and organising — Advanced

Scientific evidence management - Intermediate

Scientific product lifecycle and procedure management - Intermediate

Sub-family competencies

Regulatory frameworks and strategy — Advanced Applied knowledge — Advanced

Grade competencies Adaptability and agility — Intermediate Coping with pressures and setbacks — Advanced Analysing and problem-solving — Advanced

Core competencies Ethics and integrity — Intermediate Team collaboration — Advanced Customer centricity — Advanced Results orientation — Advanced Communication — Advanced Cross-cultural sensitivity — Advanced Continuous learning and self-development — Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Education

- Master’s degree in regulatory science, regulatory affairs, quality, manufacturing, pharmaceutical technology, or quality business leadership.

Background and/or work experience in the following areas:

- * Novel/innovative manufacturing technologies or products (e.g., ATMPs, bedside manufacturing, continuous manufacturing); and/or - Use of artificial intelligence and/or automation in pharmaceutical manufacturing activities - Regulatory affairs (which allows for a clear understanding of GMP and how it interacts with submissions of marketing authorisation application

Application timeline

This vacancy was first listed on 27 October 2026, today.

The application deadline is 22 November 2026, 25 days from today. Late applications are not accepted, so submit through the official EU Careers portal well in advance.

Last verified against the EU Careers feed on 27 October 2026.

Where to learn more

For headcount, mission, and other open vacancies at EMA see the EMA institution page; for the cost of living, correction coefficient, and other postings in Amsterdam see our Amsterdam location page.

New to EU careers? Our beginner's guide walks through entry routes, EPSO competitions, and what to prepare. For application logistics see application tips and EPSO competitions.