SNE/Scientific Specialist (science & regulation)

About this position

The Regulatory science and Academia Workstream is looking for a seconded national expert for 2 to 4 years to work full time at the EMA headquarters in Amsterdam with the team on the following tasks: 

• Contribute as EMA’s Academia liaison to the purpose of the Regulatory Science and Academia Workstream, which is to coordinate the collaboration with academia to accelerate the translation of academia-originating solutions into medicinal products, drug development tools and regulatory science progress; 
• Manage the initial interactions of researchers and developers from the academic sector, not-for-profit organisations, research networks and consortia with regulatory scientists from the Agency and regulatory network; 
• Manage the collaboration in EMA’s Academia matrix and its delivery of the action plan, strengthen the EMA Framework of collaboration with academia, and contribute to regulatory initiatives directed at academia.    

In this role you will

• Manage the initial interactions with researchers and developers from the academic sector on their plans and solutions, facilitate understanding of their challenges and discuss strategic scientific (e.g., research options) and translational aspects (e.g., valorisation activities), provide high-level support through briefing meetings, and engage them on regulatory science challenges;  
• Manage, drive and develop the collaboration in the EMA Academia matrix as a dynamic community of staff engaged with academia, manage its delivery of the action plan to create joint deliverables that increase the value of interactions with academia and of Agency initiatives directed at academia (see the previous action plan here: https://www.ema.europa.eu/en/documents/other/academia-collaboration-matrix-action-plan-2021-2023_en.pdf).  
• Provide coordination support to initiatives directed at academia (e.g. in the areas of advanced therapies, repurposing and large multi-national clinical trials, education and training opportunities), in collaboration with relevant EMA units;  
• Process requests for regulatory services by academia, e.g., validation, incentives, evaluating public health impact and scientific questions;   
• Identify strategic gaps in interactions or support for academia concerning medicines, technologies or methodologies, and profile the landscape of academic R&D;  
• Identify scientific disciplines and research topics for developing EMA expertise and recruit academic researchers into the Stakeholder database, for engaging their expertise where needed;  
• Contribute to identify gaps for advancing regulatory science and drug development tools needs; 
• Contribute to preparations for changes to the legislative framework; 
• Contribute to exchange programmes and placements to promote learning between academia and the Agency (e.g., Seconded national experts, Collaborating experts); 
• Contribute to the Taskforce delivering on the Regulatory Science Strategy 2025.  

Apply if you meet these eligibility criteria

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

You will need

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma.

Field of study
Life Science (e.g. medicine, biology, chemistry, biochemistry, pharmacy).
Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study;
• Demonstrated experience of at least 3 years in a job position managing collaborations or projects (can include clinical trials) in the biomedical field; and 
• Demonstrated expertise of at least 3 years in performing critical reviews in the biomedical field (e.g. grant application evaluation, article peer review, project evaluation, technology transfer). 

Skills & Knowledge

• Have a thorough knowledge of the landscape of actors and activities in the translational life cycle from researchers to patients; 
• Have a thorough knowledge of English language including writing scientific reports; 
• Organisational skills;
• Critical review and drafting of scientific and regulatory documents; 
• Communication and presentation skills including  scientific or regulatory matters at a high level to different audiences; 
• Proficient in using MS Office applications; 
• Understanding of the EU pharmaceutical legislation and the regulatory framework for medicinal products in the EU.  

Nice to have

Education

• PhD in Medicine or Life sciences.

Field of study

• Scientific background relevant to perform the role.

Experience

• Programmatic data collection and analysis; 
• Experience in technology transfer;  
• Clinical experience in a therapeutic field; 
• Non-clinical experience; 
• Pharmaceutical development experience; 
• Medicines assessment at a National Competent Authority; 
• Experience in working with stakeholder organisations. 

Skills & Knowledge

• Knowledge of typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
• Knowledge of methodology for quality, non-clinical, or clinical development;
• Knowledge of at least one area relevant to quality, non-clinical, or clinical development of medicines.