Вакансии

  • Москва
  • Полный рабочий день

Regulatory Affairs Specialist

31 октября 2017, 11:31

Main responsibilities:



Preparation of dossier for various regulatory submissions (NDA, Renewal, Variations, EAEU compliance), including:



  • documents translation,
  • local Normative document preparation,
  • PIL writing,
  • packaging materials artworks coordination
  • completion of the dossier.
  • Assurance of documents compliance with the regulations of the Russian Federation.
  • Assurance of timely submission and documentation flow for timely approval.
  • Monitoring of Russian regulatory environment.

Requirements:



  • University degree in Pharmacy or Natural Sciences (Pharmaceutical, Medical or Chemical)
  • Experience in regulatory area in a Pharmaceutical Company (could be minimal experience)
  • Familiar with local and EMA (desirable) regulations
  • English – upper-intermediate level
  • Advanced computer skills (Microsoft Word, PowerPoint, Excel)

 



Skills and attitude required



  • To be self-disciplined and well organised. Possess a strong sense of responsibility. Have a good track record of working organised and independently while meeting strict deadlines
  • Fast learner
  • Quality Orientation
  • Eye for detail. Able to do the “head’s down” work in addition to the other requirements.
  • Team working / Collaboration with others. Good communication skills
  • High level of self-motivation.
  • Flexibility, adaptability and proactive nature in order to meet the various demands and priorities

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