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Регуляторный менеджер/Regulatory Affairs manager

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

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Job Description

Образование/Квалификация:

  • 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

ACCOUNTABILITIES:

  • 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

Locations

Almaty, Kazakhstan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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