Description

You will lead global CMC regulatory strategies for oncology product portfolio, overseeing marketing applications and lifecycle management to secure approvals worldwide. This role involves cross-functional collaboration, health authority interactions, and mentoring junior team members.

Requirements

• Bachelor's in Pharmaceutical Science, Chemistry, Chemical Engineering or related field
• 15+ years pharmaceutical/biotech drug development experience including 5+ years global CMC regulatory
• Deep expertise in CMC development for NCEs and small molecules
• Experience leading global CMC regulatory strategy across US, Canada, Europe, UK, APAC, LATAM
• Strong knowledge of US/international GMP regulations and health authority interactions

Responsibilities

• Develop and execute global CMC regulatory strategies for marketing approvals and lifecycle management
• Oversee preparation and submission of CMC dossiers for global marketing applications and post-approval supplements
• Manage interactions with Health Authorities (FDA, EMA, etc.)
• Assess regulatory implications of CMC changes and provide risk-based guidance
• Partner with cross-functional teams to align global submission strategies