Job grade: AD08
Internal job grade and Interagency: AD08 and above
Type of position: Temporary agent
Selection procedure reference: EMA/AD/11219
Job title: Senior Environmental Risk Assessment Specialist
Talent Pool: AD08 Science & Regulation
Deadline for applications: 10 June 2026 at 23:59 CET
Salary: 8911,48 Euro (including local weighting) [1] plus benefits
Location: Amsterdam;Netherlands; (relocation to take up duties is mandatory)
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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.
In this context, EMA is looking for Senior Environmental Risk Assessment Specialist to:
- Provide expert scientific and regulatory support for environmental risk assessment (ERA) across Agency activities, including the implementation of ERA provisions for the new human pharma legislation (NPL).
- Provide expert scientific support to the work of Committees, Working Parties, the European Commission, and other relevant stakeholders. Engage in related regulatory science initiatives.
- Drive the implementation of the New Pharmaceutical Legislation (NPL) in collaboration with internal teams and external stakeholders, with a particular focus on its impact on Environmental Risk Assessment (ERA) for human medicines.
- Perform newly defined ERA-related tasks, including the catch-up procedure (a retrospective process for older medicinal products) and the development of ERA monographs.
- Manage and deliver regulatory and procedural guidance documents related to ERA, and support training activities as needed.
- Oversee and execute the establishment and coordination of a dedicated ERA Working Party, ensuring scientific, regulatory, and procedural support, and monitoring the delivery of its outputs.
- Collaborate closely with EU National Competent Authorities and other relevant stakeholders to ensure alignment and effective implementation of ERA-related initiatives.
- Actively contribute to scientific advice and protocol assistance processes on ERA topics, including participation in pre-submission meetings and Scientific Advice Working Party (SAWP) discussions.
- Identify and monitor new or recurring ERA-related topics and issues that may require further guidance or an official position from relevant committees or working parties.
- Act as EMA topic leader, when required, for ERA-related matters.
- Provide scientific training on ERA within the Agency and across the EU regulatory network, as needed.
- Engage in regulatory science initiatives related to ERA, contributing to innovation and continuous improvement in environmental risk assessment 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.
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Specific conditions:
1. possess a university degree (minimum of four 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 9 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date.
OR
2. possess a university degree 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 10 years’ professional experience after 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 4 years of demonstrated experience in ERA as applied within the pharmaceutical industry, regulatory authorities or academic research.
- Proven expertise in areas such as environmental exposure assessment, fate and effects analysis, and risk characterisation and assessment
Skills & Knowledge
- Expert knowledge and understanding of ERA for chemicals and/or pharmaceuticals as applied to medicinal product development and regulation.
- Ability to critically evaluate scientific studies and interpret their implications for public health and regulatory decision-making.
- Strong project management skills, with the capacity to take initiative, develop innovative solutions to complex challenges, and adapt to a dynamic, multi-stakeholder environment.
- Proven ability to integrate translational science considerations into the support and assessment of medicinal products, particularly in the context of scientific advice and marketing authorisation procedures.
- Demonstrated leadership capabilities, including the ability to guide scientific discussions, influence cross-functional collaboration, and contribute to strategic regulatory initiatives.
Competencies you will need to have:
Role competencies
Scientific evidence management, Advanced
Sub-family competencies
Regulatory frameworks & strategy, Advanced
Applied knowledge, Advanced
Grade competencies
Analysing and problem solving, Intermediate
Prioritising and organising, Advanced
Influencing and persuading, Advanced
Core competencies
Ethics and integrity, Intermediate
Team collaboration, Advanced
Customer centricity, Advanced
Results orientation, Advanced
Communication, Intermediate
Cross-cultural sensitivity, Advanced
Continuous learning and self-development, Intermediate
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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
- 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).
- Work experience in another regulatory field, e.g. chemicals, cosmetics or food.
- Experience of undertaking critical review and/or drafting scientific and regulatory documents for expert and/or lay audiences.
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.
- Scientific product lifecycle and procedure management.
Certificates
Certified Toxicologist (e.g. Eurotox, ABT).
Selection procedure timelines
Deadline for applications
10 June 2026 at 23:59 CET
Foreseen: week of the 29 June 2026
Foreseen: week of the 13 July 2026
Foreseen: End of July 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, Sub-family, Grade specific competencies, Role 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
In order 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 competences 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.
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.
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Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands
