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3Rs/Environmental Risk Assessment Specialist at European Medicines Agency (Amsterdam) · CodeHub Jobs

Job description

Job grade: AD06

Internal job grade and Interagency: AD06 and above

Type of position: Temporary agent

Selection procedure reference: EMA/AD/11218

Job title: 3Rs/Environmental Risk Assessment Specialist

Talent Pool: AD06 Science & Regulation

Deadline for applications: 28 April 2026 23:59 CET

Salary: 5979,74 Euro (including local weighting) [1] plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week))

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

About this position:

The revision of the European pharmaceutical legislation is a unique opportunity to reshape medicines regulation in the EU and make the EU regulatory framework more fit for innovative medicines, to promote greater access to medicines for patients and to address the major public health challenges of the future (e.g. antimicrobial resistance).

The new pharmaceutical legislation will simplify structures and procedures which have been introduced by different pieces of legislation over the years. A simplified and more integrated regulatory system will be easier to navigate for developers and aims to make Europe more attractive and competitive in the global environment.

The revised legislation will also reduce administrative burden, to help improve sustainability of the European medicines network, rationalise the use of the scientific assessment resources in the network, and become more agile in dealing with complex medicine assessments.

Here is the link to the generic Role Description, outlining the generic duties and responsibilities:

Translational Sciences Specialist (CO-01-02-140)

In this context, EMA is looking for a 3Rs/Environmental risk assessment specialist to:

Provide expert scientific and regulatory support in Environmental Risk Assessment (ERA) and/or the 3Rs (replacement, reduction and refinement of animal testing) across the Agency’s activities, including the implementation of related provisions under the New Pharmaceutical Legislation (NPL). Provide scientific support to the work of Committees, Working Parties, the European Commission, and other relevant stakeholders. Participate in regulatory science initiatives aimed at advancing ERA and 3Rs practices within the regulatory framework.
Collaborate with internal functions to support the implementation of the New Pharmaceutical Legislation (NPL), with a focus on its impact on Environmental Risk Assessment (ERA) and/or 3Rs principles for human medicines.
Contribute to and perform newly defined ERA-related tasks, such as the ERA catch-up procedure (a retrospective process for older medicinal products) and the development of ERA monographs.
Support the development and updating of regulatory and procedural guidance documents and participate in training activities as required.
Contribute to the establishment and coordination of a dedicated ERA Working Party, providing scientific, regulatory, and procedural input, and contributing to the delivery of its outputs.
Collaborate, as required under the NPL, with the European Commission, EU National Competent Authorities, and other relevant organisations (e.g. ECHA, EFSA) and stakeholders.
Provide scientific support in translational sciences, with a focus on ERA and 3Rs, across the Agency’s activities.
Actively contribute to scientific advice and protocol assistance on ERA and/or 3Rs topics, including participation in pre-submission meetings and Scientific Advice Working Party (SAWP) discussions.
Identify and monitor emerging or recurring topics that may require further guidance or an official position from relevant committees or working parties.
Act as EMA topic leader, when appointed, for specific ERA or 3Rs-related matters.
Provide scientific secretariat support to relevant working parties, drafting groups, and committees, including liaison with other groups as needed.
Deliver scientific training within the Agency and across the EU regulatory network, as required.
Engage in regulatory science initiatives related to ERA and 3Rs, contributing to the advancement of scientific and regulatory practices.

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.

Specific conditions: 

1.    possess a university degree (minimum of three years) in Life sciences (e.g. biology, biochemistry, environmental sciences, (eco)toxicology, chemistry, pharmacy, pharmacology, medical/biomedical sciences (Human/Veterinary medicine) or related subject or translational sciences, that must have been obtained by the closing date of this vacancy notice, and at least 3 years of professional experience obtaining the relevant degree, that must have been obtained by the closing date. 

General Condition 1 and Specific Conditions will 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 candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience

Out of the years of experience listed in the Specific conditions (eligibility criteria) at least 2 years of work experience with aspects of ERA or 3Rs as applied in pharmaceutical industry, the regulatory network, or academia

Skills & Knowledge

Thorough knowledge and understanding of ERA for chemicals and/or pharmaceuticals as applied to medicinal product development and regulation, and/or familiarity with the principles of the 3Rs (replacement, reduction and refinement of animal testing).
Ability to critically assess scientific studies and evaluate their implications for public health and regulatory decision-making.
Project management skills, with the ability to take initiative, adapt to evolving challenges, and work effectively with diverse stakeholders in a dynamic regulatory environment.

Competencies you will need to have:

Role competencies

Scientific evidence management, Intermediate

Sub-family competencies

Regulatory frameworks & strategy, Intermediate
Applied knowledge, Intermediate

Grade competencies

Analysing and problem solving, Intermediate
Adaptability and agility, Intermediate
Prioritising and organising, Intermediate

Core competencies

Ethics and integrity, Intermediate
Team collaboration, Intermediate
Customer centricity, Intermediate
Results orientation, Intermediate
Communication, Intermediate
Cross-cultural sensitivity, Intermediate
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

MSc or completed PhD in a field related to the areas listed above.

Experience

Experience as a study director/study monitor for in vitro or in vivo non-clinical or environmental risk assessment studies.
Experience in the preparation and/or review of application dossiers for regulatory submissions.
Experience in working with stakeholders (industry and national/international regulatory authorities).
Experience with in vitro or other technology that has the potential to replace, reduce or refine the use of experimental animals.
Experience in another regulatory field, e.g. chemicals, cosmetics or food.

Skills & Knowledge

Knowledge of the European medicine regulation.
Knowledge of typical issues encountered in the non-clinical and environmental risk assessment setting during development, manufacturing, and authorisation of pharmaceuticals, chemicals, cosmetics or food materials.
Experience of undertaking critical review and/or drafting scientific and regulatory documents for expert and/or lay audiences.
Scientific product lifecycle and procedure management

Certificates

Certified Toxicologist (e.g. EuroTox, ABT).

Selection procedure timelines

Deadline for applications

28 April 2026 23:59 CET

Preliminary Assessments

Foreseen: 04 June 2026

Final assessments

Foreseen: 22 to 25 June 2026

Decision expected

Foreseen: End of June 2026

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note: Candidates who fail any assessment linked to any Need to Have requirement, Role competencies, Sub-family competencies, Grade specific competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

To allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competencies and Role competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.

Assessments

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.

Reserve list and/or job offers

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

If Temporary Agent posts are not available, if justified in the interest of the service, candidates on the reserve list may be approached to provide written consent to be considered for Contract Agent positions. . These candidates will remain on the Temporary Agent reserve list and will be considered for a Temporary Agent post should a suitable post become available.

Contract Agent posts differ from Temporary Agent posts in terms of categories, function groups, grades and remuneration and career progression.X

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 114.6. Please consult the Eurostat and Commission websites for more information on weightings.

______________________________________________________________________________________________________

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu