3Rs/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 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.

Eligibility criteria

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), obtained by the closing date of this vacancy notice, and at least 3 years of professional experience after obtaining the relevant degree, obtained by the closing date.

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

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).

What EMA offers

Serving a population of 500 million citizens, we promote and protect public 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.

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within a multinational, multidisciplinary team.
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.).
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays).

Benefits (applicable only to Temporary and Contract vacancies)

• Initial 5 year contract with competitive monthly tax-free salary and 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.