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Regulatory Affairs Registration Manager


Aline Vandermeeren
Recruiter
+32 16 30 95 09


Jobomschrijving

  • Under supervision of a manager (eg GRL or GRL delegates), liaise with contributing disciplines to define technical file content and submission strategy related to China compliance remediation dossiers
  • Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline (eg GIO, QC, Site Conformance, etc), initiation and management of CMC submission kick-off meeting, file authoring, review and approval
  • Ensure liaison with and coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program
  • May provide technical regulatory inputs and advice to technical steering committees related to China compliance program, as appropriate
  • Together with Regulatory product responsible, agree on File preparation and submission planning; monitor progresses and take any remediation actions in case of deviations.
  • Report significant issues to management

Profiel

  •  Bachelor’s degree (Life Sciences background is preferred) or equivalent by experience.
  • Knowledge of regulatory procedures / systems / guidances
  • Knowledge of Technical Life Cycle Management and Change Control process
  • Knowledge of biological products
  • Good level of spoken and written English. Knowledge of French is an asset
  • Experience in Technical Life Cycle Management, Project Management and change control process
  • Experience in CMC authoring of technical file
  • Experience working with Biologics (if possible preferred over Pharmaceuticals)
  • Experience in China legislation would be a plus
  • Good communication skills
  • Analytical skills, creative and critical mind
  • Team player

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