Senior Manager, CMC Regulatory Affairs

The role

This person will implement and document global CMC strategies for multiple biologics programs from pre-clinical development through Phase 3 and commercialization. They will work with Manufacturing and Quality teams to shape regulatory strategy and documentation for innovative biologics.

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, highly organized, and able to thrive in fast paced environments while managing multiple priorities
• Advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related sciences
• About 8 years of relevant work experience
• Able and willing to travel (up to ~25%) to AbCellera’s headquarters in Vancouver

Benefits

• Equity
• Annual bonus dependent on individual and company performance
• 6% 401K contribution
• USD $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.