Senior Scientific Specialist (GCP) - 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:

• Contribute to/coordinate scientific and regulatory guideline development in GCP
• Provide scientific specialist expertise and regulatory support to review of GCP aspects for human and veterinary medicines across product lifecycle
• Coordinate EMA co-ordinated GCP inspections
• Coordinate and contribute to requests for technical advice on proposed new legislation
• Support collaboration with other regulatory working parties within the EU and international cooperation on GCP topics
• Present inspection topics at internal and external fora and act as 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 (biology, biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) OR university degree (minimum 3 years) in Life Science with additional professional experience
• Experience: At least 9 years relevant professional experience after obtaining degree (if 4-year degree) OR at least 10 years relevant professional experience (if 3-year degree); out of these years, at least 5 years of experience in clinical research/GCP gained from competent authority, pharmaceutical industry, or healthcare/academic setting in conduct, management, quality assurance/control or supervision of…
• Languages: English (C1), Another official language of the Europe… (B2)
• Key skills: Critical review and drafting of scientific and regulatory documents, Presenting scientific and regulatory matters at high level, Proficient in modern IT systems and ability to work with and analyse large datasets, Knowledge of EU pharmaceutical legislation and regulatory framework, Knowledge of typical issues and general methodology in clinical research, Influencing and persuading, Prioritising and organising, Scientific evidence management, Scientific product lifecycle and procedure management, Regulatory frameworks and strategy
• Eligibility: Full rights as citizen of European Union Member State, Iceland, Liechtenstein or Norway; fulfilled any obligations imposed by applicable laws concerning military service

Selection process

The notice describes the following selection steps:

• Verification of general and specific eligibility conditions based on application form
• Assessment by Selection Committee
• Interview stage with documentary evidence verification

Contract and working arrangements

Contract duration: Temporary agent.

Hiring unit: EMA Inspections' Office, Good Clinical Practice (GCP) area.

Position overview

This is the official EU Careers listing for Senior Scientific Specialist (GCP) 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/11637

Job title: Senior Scientific Specialist (GCP)

Talent Pool:AD08 Science & Regulation

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

Salary: 9577,39 Euro(including local weighting)-1163/1451820833/#_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 Clinical Practice (GCP) area of the EMA Inspections’ Office, this role is at the forefront of contributing to EU compliance oversight, safeguarding clinical trial participants, and ensuring medicines are approved based on GCP-compliant studies, while supporting innovative trial approaches to bring new therapies to patients.

The role involves contributing to strategic initiatives such as GCP guideline development, technical advice related to the implementation of legislation, inspection coordination, supporting the GCP Inspectors’ Working Group (IWG), representing inspection topics internally and externally, and international collaboration.

We are seeking a motivated professional with strong GCP expertise, a broad understanding of the product lifecycle and how GCP inspections embed into the marketing authorisation process, and the ability to balance technical knowledge with strategic thinking. An ideal candidate will have strong communication and organisation skills, the ability to work autonomously but is also a good team player, and can drive topics forward, ensuring the views of stakeholders are heard, while also contributing their own expertise.

You will work alongside leading GCP 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:

- Contribute to/co-ordinate scientific and regulatory guideline development in the area of GCP, including providing scientific and regulatory input to the GCP Inspectors’ Working Group (IWG), 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. - Provide scientific specialist expertise, coordination and regulatory support to the review of GCP aspects for human and veterinary medicines across the life cycle of the medicinal product (e.g. scientific advice, evaluation of marketing authorisations and post-authorisation variations and line extensions). - Coordinate of EMA co-ordinated GCP inspections. - Coordinate and contribute to requests for technical advice on proposed new legislation. - Support collaboration with other regulatory working parties within the EU (e.g. with the CTCG), international co-operation on GCP 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 GCP 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 (e.g. biology,biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) 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 (e.g. biology,biochemistry, chemistry, medicine, pharmacology, pharmacy, toxicology) 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 need to have:

Experience

- Out of the years of professional experience required above, at least 5 years of experience of relevance to clinical research/GCP. This experience could be gained from a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting and should have been obtained in the conduct, management, quality assurance/control (including audit/monitoring) or supervision (including inspection etc) of clinical trials.

Skills & Knowledge

- Critical review and drafting of scientific and regulatory documents for expert and lay audiences; - Presenting scientific, or regulatory matters at a high level (eg to experts); - 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; - Knowledge of the typical issues and general methodology in clinical research.

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

- Masters in a relevant field of study (Medicine or Life sciences);

- Master’s degree in regulatory science and/or affairs, clinical research, risk-based quality management, or compliance oversight.

- Experience of working in pharmacovigilance operations or oversight.

- Non-clinical experience, in particular in the area of bioequivalence/bioanalytics;

- Clinical assessment at a National Competent Authority;

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.