Apply on Kit Job: kitjob.ca/job/2fs9vu

Shape global strategies within CMC Regulatory Affairs as an Associate Director. Collaborate with manufacturing and quality teams while ensuring compliance and timely submissions for biologics programs.

As a key project team member, you will develop and implement comprehensive CMC regulatory strategies for biologics from pre-clinical to Phase 3 studies. Your expertise will ensure alignment with health authority requirements and bring innovative products to market efficiently. You will oversee regulatory submissions and coordinate with various teams to navigate critical timelines successfully.

Key Responsibilities:
• Act as primary regulatory representative in project meetings
• Prepare CMC submissions including IND and CTA filings
• Manage responses to regulatory queries




• Collaborate with teams to innovate submission strategies
• Evaluate CMC program risks and mitigation strategies

Requirements:
• Deep understanding of CMC regulatory requirements
• Experience with eCTD structure and Module 3 preparation
• Knowledge of Health Canada, FDA, and EMA regulations
• 12 years of relevant experience required
• Solid organizational and communication skills

Utilize your expertise in managing CMC submissions and ensuring compliance for innovative biologics to drive successful product development.
#J-18808-Ljbffr

Apply on Kit Job: kitjob.ca/job/2fs9vu

📌 CMC Regulatory Affairs Associate Director (West Vancouver)
🏢 Scorpion Therapeutics
📍 West Vancouver