Junior regulatory affairs specialist job opportunity at Abbott.

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DatePosted 16 Days Ago bot
Abbott Junior regulatory affairs specialist
Experience: General
Pattern: full-time
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loacation Kazakhstan - Almaty, Kazakhstan
loacation Kazakhstan - A..........Kazakhstan

      JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, and female executives. The Opportunity This position works out of our Almaty location in the Core Dx Division. What You’ll Do Work with RA colleagues and manufacturing sites RA teams to obtain required documentation per local country regulations. Prepare and submit regulatory files and documentation to Regulatory Authorities in CIS in accordance with local country regulatory requirements. Interact with translation agencies to obtain Russian translations of registration documentation. Ensure timely approval of new IVD medical devices and continued approval of marketed products. Support the local Commercial team with registration documentation for local tenders. Interact with our business partners and regulatory agency to expedite approval of pending registration. Provide metrics and feedback to management as required, keep company’s databases up to date to enable tracking of regulatory activities. Support approval of Kazakh product labels and instruction for use. Required Qualifications: Higher education (medical, pharmaceutical, chemical, biological). Some knowledge of compliance activities, adherence to quality management systems requirements, product registration activities (desirable). English - Intermediate (written). Kazakh and Russian - fluent. Advanced PC user (Word, Excel, PDF). Self-organized, scrupulousness, punctuality, initiative. Компания Abbott является мировым лидером в области медицины и помогает людям жить полной жизнью на всех ее этапах. Наши технологии, меняющие жизнь людей, охватывают широкий спектр инновационных продуктов и решений, включая диагностику, медицинские устройства, питание и лекарственные препараты. Наши 115 000 сотрудников работают на благо людей в 160 странах мира. Abbott обеспечивает доступность высококачественных лекарственных препаратов в различных терапевтических областях, завоевавших доверие врачей и пациентов во всем мире. У Вас будет возможность: •    Развивать карьеру, о которой Вы мечтаете •    Работать в международной компании, которая признана отличным местом работы в десятках стран мира, и является одной из самых уважаемых компаний в мире по версии Fortune. Приглашаем в нашу команду Младшего специалиста/ассистента по регистрации . Локация Алматы , Казахстан. Ваши обязанности: Взаимодействовать с коллегами из отдела регуляторных вопросов (RA) и командами RA на производственных площадках для получения необходимой документации. Готовить и подавать регуляторные файлы и документацию в органы регулирования стран СНГ в соответствии с местными требованиями. Взаимодействовать с переводческими агентствами для получения переводов регистрационной документации. Обеспечивать своевременное одобрение новых IVD‑медицинских изделий и поддерживать актуальность разрешений на уже выведенные на рынок продукты. Поддерживать локальную коммерческую команду регистрационной документацией для участия в тендерах. Взаимодействовать с бизнес‑партнёрами и регуляторными органами для ускорения одобрения ожидающих регистрации продуктов. Предоставлять метрики и обратную связь руководству, поддерживать актуальность внутренних баз данных. Поддерживать процесс утверждения этикеток и инструкций по применению. Требования: Высшее образование (медицинское, фармацевтическое, химическое, биологическое или другое). Базовые знания в области комплаенса, требований систем менеджмента качества, процессов регистрации продукции (желательно). Английский — уровень Intermediate (письменный). Казахский и русский — свободное владение. Продвинутый пользователь ПК (Word, Excel, PDF). Самоорганизация, внимательность, пунктуальность, инициативность.       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Regulatory Operations       DIVISION: EPD Established Pharma          LOCATION: Kazakhstan > Almaty : 1 Yedil Yergozhin Street       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: No       MEDICAL SURVEILLANCE: No       SIGNIFICANT WORK ACTIVITIES: Not Applicable                  

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