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更新于 8月23日

FSP-RA Associate Manager (MJ001135)

2.5-3.5萬
  • 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獨立完成過進口產(chǎn)品CTA注冊申報的注冊經(jīng)驗 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

北京朝陽區(qū)大望路電影產(chǎn)業(yè)園

職位發(fā)布者

展迪/人事經(jīng)理

當前在線
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)包括臨床運營、項目管理、生物統(tǒng)計、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,其臨床運營團隊覆蓋了亞、歐、北美等七個國家和地區(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。昆翎獨特的價值主張結(jié)合了其對于本地市場的了解、國際藥物研發(fā)的經(jīng)驗以及高效的團隊執(zhí)行能力。我們堅信公司強勁的管理層團隊以及其高效的執(zhí)行能力,將為昆翎的發(fā)展開啟新的篇章。
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