RA Manager招聘_优时比贸易（上海）有限公司最新招聘信息-猎才医药网

职位描述

Major accountabilitiesProduct registration1.Manages, prepares and submits regulatory applications in China2.Undertakes interactions and negotiations with Regulatory Authorities to secure and optimise regulatory approvals concordant with strategic company goals.3.Plans and prioritises maintenance activities and regulatory variations to ensure products comply with conditions of China regulatory requirements.4.Keeps up-to-date with regulatory legislation, regulations and guidances in ChinaeCTD submission1.Lead the eCTD submission task force and facilitate the implementation of eCTD submission of UCB China RA by collaborating with local and global teams2.Supporting and tracking for the CTD uploading /maintenance in Mikado. Make sure follow UCB policy/timeline (e.g. upload, review, approval in Mikado).3.Coordinate and tracking the agreed submission timeline, manage the archiving for the CTD based on China RA Archiving SOP accordinglyGRA Business Tool1.Leads the regulatory function to implement the MIKADO/U-PILOT project in China.2.Maintains the templates and manuals for the processes using MIKADO and supporting the UCB China MIKADO users from business process point of view.Vendor Management1.Ensure that translation management in China meets its expectation and role & responsibilities are well aligned to the needs by stakeholders.2.Establish the unified process in translation management in China in accordance with the translation SOP through the China RA team’s collaboration, knowledge sharing and management.Compliance management1.Electronic and paper-based Archiving of documents2.Coordinator for SOP training3.Management of Education & Training records for RA staff membersRA related inspection/audit coordinator1.Coordinate the inspection to/involving China RA, collection all document /outcome for audit, tracking the audit report and CAPA if there’s any. Coordinate any inspection to UCB products/plant from HA lead through China RA.EducationBachelor degree or above, with major in pharmacy, medical, biology, chemistry; or with major in EnglishExperienceMinimum 5 years of experience within the pharmaceutical industry.Minimum 3 years of experience work with multinational pharmaceutical company.Minimum 2 years of experience in CTD within the pharmaceutical industry.International collaboration preferred.Demonstrates ability to develop and manage internal/external business relationship. 职能类别：药品注册

公司信息

比利时优时比制药公司（UCB）始建于1928年，总部设在比利时布鲁塞尔，在英国伦敦Slough和剑桥等地拥有2个研发中心。在八十年的发展中，优时比制药公司致力于为重症患者提供更多的创新治疗方法，造福人类。优时比制药在全球业务遍布40多个国家，拥有近一万名员工。2010年全球销售收入32亿欧元。全球百强医药行业排名第33位。随着业务的不断拓展，2004年5月，优时比制药完成了对英国生物制药企业--细胞技术公司的收购。2007年9月1日，又完成了对德国许瓦兹制药集团的全球并购。至此，优时比制药公司成功地实现了全球领先的生物制药公司的战略定位。优时比制药在华机构包括优时比贸易（上海）有限公司和珠海许瓦兹制药有限公司，业务遍及全国，产品涉及中枢神经系统疾病、变应性疾病、心血管疾病、贫血和疼痛治疗等领域。创新、开拓、诚信、尽责、关爱、包容与业绩是优时比制药公司始终遵循的价值观。面向未来，比利时优时比制药公司一如既往地秉承特有的业绩、尽责、诚信、包容、关爱、开拓和创新的价值观和企业文化，将建设一个全球生物医药的领先者，首要任务是带来专家和新药，治疗各种严重疾病的患者。公司网站：http://www.ucb.com 中文网站：http://www.ucb-pharma.cn 为什么选择我们？不拘一格的用人之道公司倡导内部发掘和培养人才，并提倡员工终身学习，鼓励员工不断提高自身的竞争力。每当公司出现空缺时，我们总是优先考虑内部的优秀人才，为有能力的员工不遗余力地开辟职业发展的通道。卓越完善的人才发展战略优时比业务的多样性和国际化为其员工提供了广阔的个人发展平台。员工一旦加入我们，就会得到公司在培训、业绩表现和个人潜力挖掘等方面提供的帮助。无论您的专业和职务是什么，您都将对自己的发展前景了然于胸。我们不仅提供正规的培训，而且还通过精良的个人发展计划和在职培训等途径为您的前途指路。以人为本的管理制度公司人性化的管理制度不仅体现在对员工职业发展的高度重视，不惜血本的投入，而且更体现在尊重每个人的权利和尊严，集个人和集体的才能和行动以创造我们的竞争优势。有竞争力的薪酬体系从长远来看，为了吸引人才，保留人才，并激励人才，我们确保所提供的薪资福利具有市场竞争力。我们期待着员工能有优秀的表现并得到优厚的回报，因而把薪资和员工对公司的贡献直接联系起来。上海总公司地址：上海市西藏中路268号来福士广场办公楼2802室欢迎有意向的候选人可将简历投递至邮箱：Ucbcn.hr@ucb.com。应聘简历请在主题中注明申请职位名称。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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