Apply on Kit Job: kitjob.ca/job/2fsma1

Lead and innovate in Regulatory Affairs CMC for biologics. Drive strategic submissions and oversee health authority interactions while managing cross-functional teams effectively.
As a seasoned Director in Regulatory Affairs, you'll provide leadership on the CMC aspects of biologics throughout the product lifecycle. Your responsibilities include managing regulatory submissions, guiding project teams on strategy, and ensuring compliance with health authority regulations. With a focus on mentoring and developing your team, contribute to complex regulatory submissions ensuring high-quality outcomes are achieved.
Key Responsibilities:
• Lead CMC regulatory activities for biologics programs
• Oversee regulatory submissions like INDs and BLAs
• Advise teams on strategy and risk management




• Manage health authority interactions and meetings
• Support post-approval changes and lifecycle management
Requirements:
• 10–15 years CMC Regulatory Affairs experience
• Relevant degree in biological or pharmaceutical sciences
• Hands-on experience with Module 3 submissions
• Proven leadership and consulting background
• Strong understanding of FDA and Health Canada regulations
Utilize your regulatory expertise in a energetic environment, leading biologics compliance and submissions effectively.
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Apply on Kit Job: kitjob.ca/job/2fsma1

📌 Director of CMC Regulatory Affairs (Winnipeg)
🏢 Cencora
📍 Winnipeg