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    更新于 8月23日

    FSP-RA Associate Manager (MJ001135)

    2.5萬-3.5萬
    • 北京朝陽區(qū)
    • 3-5年
    • 本科
    • 全職
    • 招1人

    職位描述

    新藥注冊
    FSP-MNC
    The candidate must have experience in completing the CTA independently for imported products for MNC.(候選人一定要有MNC獨(dú)立完成過進(jìn)口產(chǎn)品CTA注冊申報(bào)的注冊經(jīng)驗(yàn)
    responsible for implementing regulatory strategy to obtain the regulatory approval to
    support various development, responsible for delivering high standard product licenses lifecycle management for
    the designated product group; to support line manager for regulatory intelligence collection and analysis,
    integration for regulatory strategy assessment.
    Typical Accountabilities
    ? Implement regulatory strategies to achieve in-time and high quality approval and facilitate full speed launch.
    ? Maintain product licenses through timely lifecycle management with high standard.
    ? Effectively manage the local and global regulatory support systems/information to ensure good coordination
    for all stakeholders.
    ? Establish relationship with local regulatory authorities with the guidance of senior regulatory manager.
    ? Monitor local regulatory environments and communicate to key stakeholders, support to exert regulatory
    influence through company initiatives and/or industry association joint forces.

    工作地點(diǎn)

    大望路電影產(chǎn)業(yè)園

    職位發(fā)布者

    展迪/人事經(jīng)理

    三日內(nèi)活躍
    立即溝通
    公司Logo昆翎(北京)醫(yī)藥科技發(fā)展有限公司
    昆翎(ClinChoice)是一家致力于為生物醫(yī)藥和醫(yī)療器械客戶提供高品質(zhì)一站式服務(wù)的臨床階段CRO,服務(wù)包括臨床運(yùn)營、項(xiàng)目管理、生物統(tǒng)計(jì)、數(shù)據(jù)管理、注冊事務(wù)、醫(yī)學(xué)事務(wù)和藥物警戒。昆翎已經(jīng)在中國、美國、歐洲、印度、日本和菲律賓建立了主要的臨床交付中心,目前在全球擁有1800多名員工,其臨床運(yùn)營團(tuán)隊(duì)覆蓋了亞、歐、北美等七個(gè)國家和地區(qū)。高盛直投部董事總經(jīng)理、昆翎董事會成員許小鷗先生認(rèn)為,“隨著創(chuàng)新療法在全球的增長,CRO公司提供高效、可靠的研發(fā)服務(wù)能力變得尤其重要。昆翎獨(dú)特的價(jià)值主張結(jié)合了其對于本地市場的了解、國際藥物研發(fā)的經(jīng)驗(yàn)以及高效的團(tuán)隊(duì)執(zhí)行能力。我們堅(jiān)信公司強(qiáng)勁的管理層團(tuán)隊(duì)以及其高效的執(zhí)行能力,將為昆翎的發(fā)展開啟新的篇章。
    公司主頁
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