Senior Environmental Risk Assessment Specialist

Job

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.

Read full description and requirements here: Senior Environmental Risk Assessment Specialist Job Details | EMA

Profile

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 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.

Read full description and requirements here: Senior Environmental Risk Assessment Specialist Job Details | EMA

Benefits

• Initial 5 year contract.
• competitive monthly tax-free salary (8911,48 Euro based on a fulltime contract (40hrs/week), plus benefits like expatriation or household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan

Read full description and requirements here: Senior Environmental Risk Assessment Specialist Job Details | EMA

Company profile

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and safety monitoring of medicines.

Company activities

At EMA we foster scientific excellence in the evaluation and supervision of medicines.

EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a community of around 450 million people living in the EU, and has been operating since 1995.

Contact

Please visit EMA Careers Website to find full details about this vacancy and the selection process: Senior Environmental Risk Assessment Specialist Job Details | EMA