Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada

Exciting opportunity for a seasoned professional to lead and execute global CMC regulatory strategy and submissions for biological products. Oversee regulatory filings, ensure compliance with US and Canadian requirements, and act as the subject matter expert on biologics. Ideal for candidates with extensive CMC regulatory experience and expertise in biologics manufacturing.

Skills

• cmc regulatory strategy
• regulatory submissions
• biologics manufacturing
• ich guidelines
• maa submissions
• post-approval lifecycle management
• quality change management
• regulatory impact assessment
• annual report preparation
• biologic product reporting
• project management
• cross-functional collaboration
• regulatory compliance
• post-approval compliance
• regulatory documentation
• stakeholder management
• international team leadership