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Innoforce

Senior Manager to Associate Director, CMC RA

Senior Manager to Associate Director, CMC RA

Job Responsibility:

  • Adherence to Innoforce and industry code of conduct, ethics and good regulatory practices including regulatory and other required RA SOPs.
  • Implement regulatory enhancement in achieving rapid and high pass rate IND approval and facilitating rapid growth of CDMO business.
  • Effectively manage the local and global regulatory support systems/information to ensure good coordination for all stakeholders
  • Monitor local regulatory environments and address for key stakeholders with analysis, support to exert regulatory influence through company initiatives
  • Assist Issue Management.
  • Effective Teamwork, Share best practice examples & learning with the team and global colleagues

Job Requirements:

  • Bachelor or above in Pharmacy, Medical, Biology or related field
  • Have a proven track record from top pharma/CDMO company is a plus.
  • > 3 years experience in manager position or >5 years in specialist position.
  • Experience in cell and gene therapy product development, or manufacturing and QA/QC is preferred.
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