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Регуляторный менеджер/Regulatory Affairs manager

Job ID R0039308 Date posted Jun. 15, 2021 Location Almaty, Kazakhstan

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Job Description


  • Наличие высшего образования, предпочтительно  фармацевтического,  медицинского, биологического  или химико-технологического образования;
  • Опыт работы в области регистрации – не менее 3 лет  
  • Знание законодательства в области регистрации лекарственных препаратов в Республике Казахстан
  • Владение иностранным языком (английский язык)
  • Ideally have at least 3  years of experience in the same position
  • Higher education (pharmaceutical, medical, biological)
  •  Knowledge of medicines registration legislation (Kazakhstan)
  • Ability to build a productive partnership with different external and internal stakeholders
  • English language not lower than Intermediate

Необходимые компетенции:

  • Аккуратность в работе, внимательность, ответственность
  • Способность принимать решения
  • Построение эффективных взаимоотношений
  • Умение предвидеть ситуацию и действовать на опережение
  • Умение воздействовать и убеждать
  • Личная организованность, исполнительность, целеустремленность
  • Логическое мышление, хорошие аналитические и организаторские способности
  • Стрессоустойчивость, коммуникабельность.
  • Ability to proactively face and solve potential or actual problems
  • Attentive to details
  • Good internal and external communicator, cross-functional collaboration
  • Ability to deal with complexity
  •  Results-oriented
  •   Sociability, systematic, attentiveness, punctuality, the ability to work under pressure and to strict deadlines


  • Documentation/dossiers assessment against normative requirements, ensuring proper and timely communication on new and changed regulatory requirements to GRA and within the organization
  • Participate in the development and execute regulatory plans for new drugs and maintaining licenses/authorizations for the approved ones; provide sound regulatory decisions and justifications of any proposed regulatory strategy; potential regulatory risks assessment
  • Communicate with the global RA/manufacturers within satisfying additional requests and comments of the regulatory authorities
  • Ensuring effective Regulatory Health Authority interactions
  • Monitoring of applicable regulatory requirements
  • Negotiate with State Authority’s officials; follow-ups with the authorities regarding all regulatory matters in KZ
  • Perform registration, renewal, variation procedures, artworks development
  • Collaborate with the internal stakeholders concerning the timelines of regulatory activities to ensure uninterrupted supply of the products and launch of new products


Almaty, Kazakhstan

Worker Type


Worker Sub-Type


Time Type

Full time