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SNE/Regulatory Affairs Specialist

Type of position:  Seconded National Expert
Job Type:  22 August 2022 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE/Regulatory Affairs Specialist

Deadline for applications: 22 August 2022 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 and animal 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

In the Veterinary Regulatory and Organisational Support service a need has been identified for a specialist with subject matter expertise in regulatory affairs. The incumbent will provide regulatory intelligence, internally and externally, to support the activities of Veterinary Division staff, the Agency’s Committee on Veterinary Medicinal Products, and stakeholders, throughout the lifecycle of veterinary medicinal products, to ensure that the Veterinary Division’s outputs are in compliance with applicable EU legislation and guidelines. This may include the provision of regulatory support to implementation of Regulation (EU) 2019/6 and related acts. Adaptation of Product information for approved centrally authorised veterinary medicinal products to the QRD v.9 template and transitioning the former NTA guidance documents to EMA/CMDv guidance will be key focus areas. Furthermore the SNE, apart from providing specialised trainings to the V-SR-ROS team will act as an advisor in her/his specialised field and support the service when specialist knowledge is needed. 

In this post you will:

 

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


•    Development, evaluation and surveillance of medicinal products for veterinary use and of Maximum Residue Limits for substances for veterinary use;
•    Referrals and related procedures for medicinal products for veterinary use;
•    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 regulatory field.
 

Eligibility criteria

•    Enjoy full rights as a citizen of a European Union Member State or Iceland, Liechtenstein and Norway; 
•    A thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2); 
•    Be currently employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State and for the foreseeable time of the tenure as SNE remain in such employment.
 

Nice to have

Experience

•    Regulatory scientists/product manager experience;
•    Analysis and reporting on scientific/regulatory matters;
•    Pharmaceutical development experience;
•    Experience in evaluation and surveillance of veterinary medicinal products ;

______________________________________________________________________________________________________

 

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. 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)

Benefits

(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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