Senior Environmental Risk Assessment Specialist

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. 

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).