3Rs/Environmental Risk Assessment Specialist

Job

In the context of New Pharma Legislation, 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.

About the new pharma legislation (NPL):

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.

Read full description and requirements here: 3Rs/Environmental Risk Assessment Specialist Job Details | EMA

Profile

To be eligible for consideration for this position, you are required to meet the following conditions:

• enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
• 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);
• have fulfilled any obligations imposed by applicable laws concerning military service.
• 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 after obtaining the relevant degree, that must have been obtained by the closing date. 
• Out of these 3 years of experience at least 2 years of work experience with aspects of ERA or 3Rs as applied in pharmaceutical industry, the regulatory network, or academia.

Read full description and requirements here: 3Rs/Environmental Risk Assessment Specialist Job Details | EMA

Benefits

• Initial 5 year contract.
• competitive monthly tax-free salary (5979,74 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

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.

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.