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Takeda Pharmaceuticals Associate Manager, China CMC Regulatory Affairs, Beijing in Beijing, China

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Job Description


  • 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.


  • BS/BA Degree required with 3+ 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.


Beijing, China

Worker Type


Worker Sub-Type


Time Type

Full time