Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)

📋 Description

• Lead global CMC regulatory strategies for commercial biologics and vaccines.
• Support regulatory activities: variations, changes, site transfers, specs.
• Author/review CMC documentation Modules 1–3 for submissions.
• Perform CMC dossier assessments and regulatory gap analyses.
• Support global submissions US, EU, and international markets.
• Assess regulatory impact of changes to products and processes.

🎯 Requirements

• 7+ years in CMC Regulatory Affairs or CMC Strategy.
• Post-approval CMC experience with biologics/vaccines.
• Hands-on lifecycle maintenance: post-approval supplements, variations, etc.
• Strong understanding of FDA, EMA, and international regulators.
• Experience with global submission strategy and execution.
• Authoring/reviewing CMC Modules; high-quality docs.

🎁 Benefits

• Full-time remote opportunity based in Canada.
• Dedicated client partnership with long-term regulatory impact.
• Meaningful work in biologics and vaccines lifecycle management.
• Exposure to US/EU and international regulatory frameworks.
• Opportunity to expand expertise in biologics and post-approval CMC strategy.
• High level of ownership and visibility as a strategic regulatory partner.