Senior CMC Regulatory Affairs Manager

The role

The Senior CMC Regulatory Affairs Manager will implement and document global CMC strategies for multiple biologics programs from pre-clinical development through Phase 3 and commercialization. This role works with Manufacturing and Quality teams to shape regulatory strategy and ensure submissions align with global health authority requirements.

What you will do

• Leading the planning, authoring, review, and execution of global CMC regulatory submissions
• Leading or contributing to the development of responses to health authority queries
• Providing strategic CMC regulatory guidance and critical review of technical documentation
• Managing critical CMC regulatory timelines and deliverables
• Staying on top of detailed knowledge of the global regulatory environment relevant for biologics
• Identifying regulatory CMC program risks and establishing mitigation strategies
• Assessing CMC change controls for regulatory impact
• Partnering with CMC, Discovery, Quality, and Clinical Development teams to innovate strategies

Required qualifications

• Deep understanding of CMC regulatory requirements, eCTD structure, and experience in Module 3 preparation and authoring (INDs/IMPDs and BLAs/NDAs/NDSs) for biologics and combination products
• Experience developing and executing CMC regulatory strategies and submissions for biologics and combination products, including pre-filled syringes, auto-injectors, and other drug-device delivery syst
• Thorough understanding of Health Canada, FDA, and EMA regulations
• Skilled regulatory professional and technical writer with effective oral communication skills
• Detailed-oriented and highly organized
• Advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related sciences
• About 8 years of relevant work experience

Benefits

• Equity
• Annual bonus dependent on individual 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

Before you apply

• Submit application through website and refer to Job ID 23397 in cover letter
• Only selected candidates will be contacted for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.