SNE/Regulatory Affairs Specialist

Type of position: Seconded National Expert

Deadline for applications: 18 June 2026 at 23:59 CET

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

About this position

In the EMA’s Veterinary Division, we are looking for a seconded national expert to join the regulatory affairs team, which provides regulatory advice to the Veterinary Division, the EMA’s veterinary committees, applicants and other stakeholders during the development and lifecycle of centralised veterinary medicines.

The veterinary regulatory affairs team leads on consultations with the EMA’s Legal Department and European Commission on regulatory matters, seeking to achieve a harmonised approach within the EU network (e.g. together with CMDv) and, where applicable, consistent with related areas for human medicines. The team’s strategic objectives are currently shifting from consolidating the implementation of the veterinary medicines Regulation to preparing for upcoming legislative changes e.g. the Biotech Act and other horizontal legislation.

In this role you will:

• Respond to regulatory queries and prepare/review guidance for a wide range of topics, with particular emphasis on product information (QRD template v.9+) for veterinary medicines.
• Provide regulatory support to pre-submission meetings with applicants, and for ongoing pre- and post-authorisation procedures, including risk-based regulatory compliance checks before transmission of formal outputs to applicants or the European Commission (e.g. review of CVMP opinions).
• Present complex regulatory requirements in a clear and structured way, verbally or in writing, to stakeholders, for example at CVMP meetings or EMA info days.
• Contribute to internal and external negotiations amongst stakeholders to reach mutually acceptable, regulatorily compliant outcomes.

Adaptive communication, diplomacy skills and self-confidence when presenting are key to this role. You will be an analytical thinker with the ability to spot risks and to provide strategic regulatory advice in a timely manner.

Apply if you meet these eligibility requirements:

• You are national of an EU or EFTA Member State or a candidate country as decided by the Council.
• You have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (B2 level).
• You are currently employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma.
• Field of study: Veterinary medicine or Life Science (e.g. biology, chemistry, biochemistry, pharmacy) or EU pharmaceutical law.

Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study.
• Experience obtained in the regulatory and procedural aspects of the research, development, authorisation or maintenance (post-authorisation lifecycle management) of veterinary medicines, either as a regulator in the field of veterinary medicines, or in the pharmaceutical industry or consultancy setting.

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences.
• Presenting scientific or regulatory matters at a high level, including to experts.
• Proficient in English language.
• Proficient in MS Office suite.
• Knowledge and understanding of the veterinary EU pharmaceutical legislation and the regulatory framework for veterinary pharmaceutical products in the EU.
• Knowledge and understanding of the product information (QRD template v.9+) for veterinary medicinal products.

Nice to have

Education

• Master’s degree or other post-secondary education in regulatory science and/or affairs.

Experience

• Experience as a Regulatory Affairs professional on EU-wide procedures or national procedures or other work on the regulation of medicines.
• Experience working for a multinational organisation and managing multiple international stakeholders.

Skills & Knowledge

• Working knowledge of the Union Product Database.

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).