SNE/Scientific Specialist (Veterinary Biologicals and Emerging Therapies)

About this position:

The European Medicines Agency (EMA) is seeking a motivated Seconded National Expert (SNE) to join the Veterinary Biologicals and Emerging Therapies department (V-EI-BIO) at an exciting time of growth and transformation. As innovation in veterinary medicines accelerates, the number and complexity of marketing authorisation applications for biologicals, including immunologicals and novel therapies continue to increase. This role offers a unique opportunity to work at the forefront of regulatory science, contributing to the evaluation of novel technologies and helping shape the future regulatory framework established by the Biotech Act (BTA).

The successful candidate will play a key role in supporting the assessment and lifecycle management of novel veterinary therapies, including the development, implementation and follow-up of Risk Management Plans (RMPs), and other biological products.

The position will involve working closely with scientific committees, the Novel Therapies Working Party (NTWP), external experts and the European Commission to address complex scientific and regulatory challenges. It offers a unique opportunity to contribute to the classification and assessment of innovative veterinary products, support network-wide capacity building, and help establish processes and requirements that will underpin future regulatory activities in this rapidly evolving field.This position is ideal for professionals with a strong scientific background and an interest in veterinary biologicals, innovation, stakeholder engagement and regulatory policy. By joining EMA, you will have the opportunity to make a meaningful contribution to the development and availability of innovative veterinary medicines, while helping to strengthen Europe's preparedness for the next generation of veterinary medicines.

In this role you will:

• Support the scientific and procedural management of marketing authorisation applications for veterinary biologicals, including immunologicals, and novel veterinary therapies.
• Contribute to the assessment, implementation, and lifecycle monitoring of Risk Management Plans (RMPs) for novel therapies.Support the development and implementation of the regulatory framework for novel therapies under the Biotech Act, helping ensure organisational readiness for future legal requirements.
• Coordinate and contribute to the classification and scientific assessment of novel veterinary products, providing case-by-case scientific input and regulatory recommendations.Liaise with the Novel Therapies Working Party (NTWP), Operational Expert Groups (OEGs), external scientific experts, and other stakeholders to facilitate scientific discussions and regulatory decision-making.
• Contribute to interactions with the European Commission and the European medicines regulatory network on matters related to veterinary medicines and novel therapies.
• Contribute to the development and delivery of training and knowledge-sharing activities for the European medicines regulatory network on novel therapies and emerging technologies.Help identify and address evolving scientific and regulatory challenges associated with innovative veterinary medicinal products, contributing to the continuous development of regulatory practices and guidance.

Apply if you meet these eligibility criteria:

1. Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine; 
2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the EU (at least level B2); 
3. Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional /local public administration) in an EU Member State and are due to remain in such employment for the foreseen duration of the SNE position.

Essential requirements

Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study; 
• Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry, national ethics body or in a healthcare / academic setting should have been obtained in:  
  • The scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines 
  • Working with medicinal products containing medical devices and associated regulatory framework. 

Skills & Knowledge

• Critical review and drafting of scientific and regulatory documents for experts and lay audiences 
• Presenting scientific or regulatory matters at high level 
• Knowledge and understanding of The EU pharmaceutical legislation on the regulatory framework for pharmaceutical products in the EU. 

These are considered as nice to have:

Education

• Masters in a relevant field of study (Medicine or Life sciences);
• Master’s degree in regulatory science and/or affairs.

Field of study

• Scientific background relevant to perform the role.

Experience

• In information analysis and reporting on scientific/regulatory matters; 
• Clinical experience in a therapeutic field; 
• Pharmaceutical development experience; 
• With medicines assessment at a National Competent Authority; 
• Regulatory scientists/product manager experience; 
• Non-clinical experience;
• Experience in the preparation and/or review of any part of a clinical trial application dossier or scientific advice application; 
• Experience in working with stakeholders (industry and national/international authorities)  

   

   

   

  Skills & Knowledge

  Understanding of medicines regulation.