Senior Manager, CMC Regulatory Affairs

Required

• Partnering with CMC, Discovery, Quality, and Clinical Development teams to innovate strategies to accelerate submission timelines and work as a key member of project teams
• You have a 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
• You have 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 systems, with a strong understanding of associated regulatory documentation requirements
• You have a thorough understanding of Health Canada, FDA, and EMA regulations
• You are a skilled regulatory professional and technical writer with effective oral communication skills
• You are a detailed-oriented individual, highly organized, and thrive in fast paced environments while managing multiple priorities.
• You hold an advanced degree or Bachelor’s degree in biological, pharmaceutical, chemical, engineering sciences, or a related sciences, plus about 8 years of relevant work experience
• You’re able and willing to travel (up to ~25%) to AbCellera’s headquarters in Vancouver to collaborate with your CMC teammates and other colleagues