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SNE/Scientific Specialist in the Inspections Office - GCP/GVP/GLP workstream

Type of position:  Seconded National Expert
Job Type:  15 September 2022 at 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE/Scientific Specialist in the Inspections Office - GCP/GVP/GLP workstream

Deadline for applications: 15 September 2022 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.


This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our Careers portal.



About this position


The Agency is looking for a Seconded National Expert /Expert in clinical trials and Good Clinical Practice (GCP). 
A Seconded National Expert / Expert position is available in the GCP/GVP/GLP workstream of the Inspections Office. 

The role is to:

•    contribute to the coordination of GCP and, if required, pharmacovigilance or Good Laboratory Practice (GLP) inspections;
•    provide scientific support to the GCP Inspectors Working Group and its subgroups;
•    contribute to strategic projects of the Agency;
•    provide support in the coordination of drafting groups for guidelines in the area of GCP;
•    support international collaboration in GCP inspection related activities.

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 the areas of GCP, GVP and GLP.

Role duties & responsibilities


Provide scientific coordination and regulatory and/or procedural support in relation to the any of the following areas:


  • Development, evaluation and surveillance of medicinal products for human or veterinary use and of Maximum Residue Limits for substances for veterinary use;
  • Referrals and related procedures for medicinal products for human or veterinary use;
  • Management of requests for scientific advice, protocol assistance, parallel scientific advice with other decision makers (e.g. FDA or HTA bodies), as well as qualifications;
  • Preparing the summary report and supporting the coordination of the initial assessment for orphan medicine designation, paediatric investigation plans or limited markets classifications;
  • The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles;
  • 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;
  • Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc and related activities; 
  • Respond to the requests for information received by the EMA in the scientific field.

Essential requirements




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


  •  Life Science (e.g. Pharmacy, Medicine and/or other biomedical sciences).



  • 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, GCP inspections and / or clinical assessment or, in a comparable position in the pharmaceutical industry or in a healthcare / academic setting should have been obtained in:
  • Scientific and / or regulatory aspects of research, development, GCP inspections or clinical assessment of human medicines.


Skills & Knowledge


  • Organisational skills;


  • Communication skills;


  • Critical review and drafting of scientific and regulatory documents for expert and lay audiences;


  • Presenting scientific, or regulatory matters at a high level (including experts);


  • Proficient in English language;


  • Proficient in MS Office suite;


  • Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;


  • Knowledge of the typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;


  • Knowledge of general methodology for quality, non-clinical, or clinical development;


  • Knowledge of at least one area relevant for quality, non-clinical, or clinical development of medicines.



Nice to have




  • 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.




  • 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;


  • Nonclinical experience;


  • Experience in the preparation and/or review of any part of an application dossier;


  • Experience in working with stakeholders (industry and national/international authorities).



Skills & Knowledge


  • Understanding of medicines regulation.




Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email


© European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged.

Join us to work for every patient in Europe!

Who we are?

Serving a population of 500 million citizens, we promote and protect public animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. 

What do we offer?

  • Meaningful work contributing to protecting the health of every individual and animal in Europe within 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)


(applicable only to Temporary and Contract vacancies) 

  • Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
  • Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
  • Relocation assistance
  • Excellent  health insurance scheme and social benefits
  • Retirement Pension Plan 

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