Regulatory Affairs Manager

  • Компания: Takeda
  • Город , Kazakhstan,
  • Зарплата:
  • Размещено: 2025-06-22 07:43:09

Описание

Description

Job Title: Regulatory Affairs Manager

Location: Kazakhstan, Almaty

How you will contribute:

Осуществление регистрации/ перерегистрации/ внесения изменений лекарственных препаратов в соответствии с местными нормативными актами и/или законодательством ЕАЭС.Запрос рег. досье у производителя, подготовка, подача в РО и отслеживание этапов экспертизы.Разработка и согласование локальных регистрационных документов, таких как инструкция по применению, макеты упаковок с подразделениями Компании/странами ЕАЭС/производственной площадкой;Взаимодействие с ГО для своевременного утверждения регистрации/ перерегистрации/ внесения изменений.Взаимодействие с коллегами из ЕАЭС стран ( РФ, РБ) для планирования, подачи и утверждения процедур приведения в соответствие/внесение изменений согласно правилам ЕАЭС.Взаимодействие с глобальной командой регистрации и производителем для планирования, подачи, подготовки досье и ответа на запросы РО.Техническая поддержка менеджеру по регистрации в отношении глобальных регуляторных систем, а именно ведение и своевременное обновление базы данных.Заключение договоров с РО на экспертизу, обеспечение оплаты всех пошлин;Одобрение промоционных и медицинских материалов;Отслеживание и подача в РО Периодических Отчетов о Безопасности (ПООБ);Обеспечивать координацию работы департамента со структурными подразделениями Компании и осуществлять регуляторную поддержку кросс-функциональных проектов;

What you bring to Takeda:

высшее образование и стаж работы не менее двух лет в сфере регистрации лекарственных средствопыт подач по ЕАЭС законодательствууровень английского языка не ниже Up-intermediate (В2)хорошее владение ПК, технические навыки для работы в компьютерных системах и базах данных умение быстро обучатьсяхорошие коммуникационные и организаторские навыкиумение работать в команде

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Almaty, Kazakhstan

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

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