SNE/Scientific Specialist in the Inspections Office
European Medicines Agency
Amsterdam, Noord-Holland
Vast
Voltijds
1 maand geleden
Type of position: Seconded National ExpertJob title: SNE/Scientific Specialist in the Inspections OfficeDeadline for applications: 07 September 2025 at 23:59 CETThe 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.This announcement is governed by the . For further information please visit our .About this position:The Agency is looking for a Seconded National Expert / Expert in the Inspections Office.This position will be to support the inspections office during an exciting phase of development of how we regulate, to best support the needs of our stakeholders, and the protection of patient and animal health. These include the implementation of the new pharma legislation (NPL), supporting the development of GxP guidance in the areas of computerised systems and AI and the establishment of an EU wide collaboration on third country GMP inspections for CAPs and NAPs conducted by EU NCAs. The SNE will be at the centre of helping to deliver this change, and work with top experts from the EMA Inspections Office, other parts of the EMA, and inspectorates via the network.More specifically, the SNE will support Inspection Office activities relating to the NPL, including set-up of a quality management system (QMS) related to the proposed EMA inspectorate.The SNE will also translate key concepts relating to computerised systems/AI, including those learned from Annex 11 and 22, to GCP and PV guidelines/documents.Concerning the planning of third country GMP inspections, the work will include facilitating the exchange of information from EU NCAs on third country inspections for NAPs to make efficient use of resources and avoid duplication.The SNE would be expected to contribute to core activities and work across GMP and GCP/GVP/GLP workstreams within the inspection office.The position is offered for an initial period of two years with a possibility for extension. You will join a team of senior specialists.In this role you will:
Provide scientific coordination and regulatory and/or procedural support in relation to the following areas:
Development, evaluation and surveillance of medicinal products for human or veterinary use;
Apply EU pharmaceutical legislation to the operations of the Agency as required;
Lead to the development of regulatory and/or procedural guidance documents and provide training as required;
Contribute to and support discussions at the Inspectors' Working Groups, and lead drafting groups/subgroups.
Respond to the requests for information received by the EMA in the scientific field.
Liaise with internal and external stakeholders and interested parties, internal and external subject experts;
Coordinate, support, lead effective communication and relations;
Daily internal communication and interaction related to the management of the procedures with other colleagues across the Agency and the extended product team members.
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 also need to have:Experience
3 years from the time when a university degree was awarded on completion of a minimum of three years of study as a GMP, GCP or GVP inspector, with an interest in computerised systems/use of AI during the product lifecycle, and knowledge of quality management systems. While the SNE is not expected to be an expert in all areas of GxP, they should be open minded to apply learnings across GxP areas.
Skills & Knowledge
Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
Ability to manage projects, and receive buy-in from all stakeholders, with a focus on efficient and outcome driven practices;
Knowledge of inspectorate Quality Management Systems;
Presenting scientific, or regulatory matters at a high level (including to experts);
Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU.
Nice to haveEducation
Masters in a relevant field of study (Medicine or Life sciences);
Scientific background relevant to perform the role.
Experience
Conducting or being subject to audits under the Joint Audit Programme.
Set-up of an inspectorate Quality Management System.