SNE/Scientific Specialist (Inspections Office)

About this position:

The European Medicines Agency (EMA) is a decentralised agency of the European Union based in Amsterdam, the Netherlands, at the heart of Europe’s medicines regulatory system. EMA plays a vital role in the protection and promotion of human and animal health, ensuring that safe, effective, and high quality medicines are available to patients across the EU through robust scientific evaluation and oversight.

EMA is offering an opportunity for a Seconded National Expert (SNE) to join the Inspections Office in the manufacturing stream. 

The position is to support a range of core activities across the Inspections Office, including (adjustable depending on the needs of the office):  

• GMP inspection co-ordination with EU NCAs for centrally authorised product inspections 
• GMP product support for pre-approval and post-approval centrally authorised products 
• Coordinating quality defects, falsifications, non-compliance statements and rapid alerts for centrally and nationally authorised products (as required) 
• Supporting work of the GMDP IWG, including involvement in and leading drafting groups, supporting use of digital technologies in inspections, and 
• International cooperation in relation to inspection planning and sharing of compliance information (including Mutual Recognition Agreements). 

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 job 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.

In particular, scientific specialist will: 

• 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 an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• 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).

You will also Need to Have:

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma in Life Science (e.g.: Pharmacy, Medicine, and/or other Biomedical Sciences).

Experience

• At least 3 years experience, from the time when university degree was awarded on completion of a minimu of three years experience as a GMP inspector 

Skills & Knowledge

• Critical review and drafting of scientific and regukatory documents for expert and lay audiences; 
• Ability to manage projects, and receive buy-in information from all stakeholders, with a focus on efficient and outcome drive practices;
• Knowledge of inspectorate Quality Management Systems; 
• Presenting scientific, or regulatory matters at a high level (including experts);
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;

Certificates 
n/a

Nice to have

Education

• master in a relevant foeld of study (medicine or Life Sciences)

Experience

• Scientific background relevant to perform the role; 
• Conducting or being subject to audits under the Joint Audit Programme. 

Skills & Knowledge

• Project Management. 

Certificates 
n/a