锦鲤求职岗位描述
点击“申请”按钮，即代表本人理解本人已经正式开始进入武田工作申请流程，并且本人同意武田的隐私通知、隐私政策和使用条款 。
工作描述
ACCOUNTABILITIES
With minimal supervision, executes and manages regulatory submission for assigned projects.
With supervision, prepares CMC submission dossier, helps define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement.
With supervision, participates Health Authority interactions and support CMC consultation meetings preparation with Health Authority on CMC related matters.
With moderate supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval.
With moderate supervision, support Health Authority on-site inspection on CMC RA related matters.
Ensure line management is apprised of developments that may impact regulatory success, communicating in professional and timely manner.
Evaluates change proposals for regulatory impact with supervision, and helps plan variations and amendments.
Ensure compliance with all applicable Takeda SOPs, and local and international regulations.
R&D Qualifications & Skills
BS/BA Degree required with 4+ years of relevant Industry, academic or HA experience; advanced degree preferred
Experience with CMC regulatory and regulatory, or equivalent industry experience.
Ability to understand, apply and articulate regulatory CMC requirements for drug development and post-market support initiatives required.
Demonstrates attention to detail and problem-solving abilities.
Exercise appropriate judgement when working with project teams.
Excises good judgement in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills required.
地点
CHN - Shanghai - Research and DevelopmentCHN - Beijing - Research and Development
员工类型
员工
员工子类型
正式
时间类型
全职