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Associate Director, CMC Regulatory Affairs

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AbCellera Biologics

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Location:
Canada , Vancouver

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

141000.00 - 170000.00 CAD / Year
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Job Description:

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our manufacturing and quality teams to develop and implement global CMC strategies for multiple biologics programs, from pre-clinical through Phase 3 studies. You will be a key member of project teams, shaping the CMC RA strategy and documentation for innovative new biologics and ensuring submissions are aligned with health authority requirements and delivered on time with quality.

Job Responsibility:

  • Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
  • Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
  • Overseeing the preparation of responses to regulatory authority queries
  • Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
  • Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
  • Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
  • Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
  • Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

Requirements:

  • Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
  • Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
  • Thorough understanding of Health Canada, FDA, and EMA regulations
  • Ability to efficiently oversee independent contractors and vendors
  • Skilled regulatory writer with effective oral communication skills
  • Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
  • Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
  • About 12 years of relevant work experience
What we offer:
  • Equity
  • Annual bonus dependent on team and company performance
  • 6% (non-match) RRSP contribution
  • CAD $1,500 annual Active Lifestyle Allowance
  • Annual vacation
  • Professional development opportunities
  • Comprehensive health benefits
  • Scientific and technical mentorship

Additional Information:

Job Posted:
March 05, 2026

Employment Type:
Fulltime
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