延吉招聘

职位描述：

GRA business tool systems

-        Lead the regulatory function to implement the global business tool systems in China.

-        Maintain the templates and manuals for the processes using the global business tool systems and supporting the UCB China users from business process point of view.

Compliance management

-        Electronic and paper-based archiving of documents

-        Coordinator for SOP training

-        Management of education & training activities for RA staff members including onboard training

Coordinator for local process

-        Monitor the local implementation of process such as new E2E Labeling process.

-        Provide needed training to the team

-        Help team to track on general system and task related activities

eCTD submission

-        Lead the eCTD submission task force and facilitate the implementation of eCTD submission of UCB China RA by collaborating with local and global teams

-        Support and track for the CTD uploading /maintenance in systems. Make sure follow UCB policy/timeline (e.g. upload, review, approval in systems)

-        Coordinate and track the agreed submission timeline, manage the archiving for the CTD based on China RA Archiving SOP accordingly

Vendor Management

-       Ensure that translation management in China meets its expectation and role & responsibilities are well aligned to the needs by stakeholders.

-       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.

Coordinator for RA related inspection/audit

-        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.

任职要求：

Education

-       Bachelor degree or above, with major in pharmacy, medical, biology, chemistry; or with major in English

Experience

-       Minimum 3-5 years of experience within the pharmaceutical industry

-       Experience in multinational pharmaceutical company preferred

-       Experience of regulatory affairs in pharmaceutical field preferred

-       Experience in CTD/eCTD within the pharmaceutical industry preferred

International collaboration preferred

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：******************
中文网站：************************

为什么选择我们？

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。

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：chinacampus@ucb.com。应聘简历请在主题中注明申请职位名称。