Executive Director, Regulatory Affairs

Job Summary

A company is looking for an Executive Director, Regulatory Affairs CMC.

Key Responsibilities

• Plan, implement, and manage regulatory submissions for compounds in various phases of development
• Provide regulatory strategies and identify gaps in CMC development for global drug product approvability
• Lead and mentor a team of CMC professionals, fostering a collaborative culture

Required Qualifications

• Advanced degree (Ph.D. preferred) in a relevant scientific field
• 12+ years of experience in pharmaceutical development and regulatory CMC, with 8+ years in a leadership role
• Deep understanding of US, EU, and Japan regulations for drugs/biologics
• Extensive knowledge of FDA, EU, ICH, and PMDA guidelines governing CMC development
• Experience in drug substance and drug product development