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abcellera

7 days ago

Senior CMC Regulatory Affairs Manager

Onsite Vancouver

go regulatory affairs

greenhouse

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Job description

You will manage global CMC regulatory submissions for biologics programs in Vancouver. This role involves collaborating with cross-functional teams to ensure compliance with health authority requirements.

Details

  • Vancouver, work from office
  • CAD $150,000 - $180,000 annually
  • 8+ years of relevant work experience
  • Advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or related sciences

The work

  • Lead planning and execution of global CMC regulatory submissions
  • Develop responses to health authority queries
  • Provide strategic CMC regulatory guidance and review technical documentation
  • Manage CMC regulatory timelines and deliverables