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2年经验 -
本科 -
招1人 -
03-07 发布
- 五险一金
职位描述
*Responsibilities/DutiesPrepare routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs, HGRAC, Import permits, export permits and NDAs) in China.Will take ownership for specific pieces of work and may be the Regulatory Affairs lead for projects.Review/summarize/compile scientific/research documents in preparation for submission to Regulatory Authorities.Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.Responsible for maintaining awareness of regulatory legislation, guidance and practice pertaining to assigned product/project areas.Assure compliance with regulatory requirements in relation to assigned projects.Participate in project development and regulatory strategy planning sessions. Will participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.Work on special regulatory projects as assigned.*Education/QualificationsBachelor’s Degree in Life Sciences or equivalent.*ExperienceMinimum Required:？Excellent communication skills, organization and planning skills and attention to detail.？Minimum of 3 years experience in the pharmaceutical industry preferably in regulatory affairs or drug development. 职能类别： 药品注册 关键字： 药品注册， 药品申报
联系方式
酒仙桥路10号恒通商务园20号楼
公司信息
Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!
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