CMC Regulatory Affairs Director

Job Summary

A company is looking for an Associate Director in Global Regulatory Affairs, CMC, Gene Therapy.

Key Responsibilities

• Lead CMC regulatory activities for complex projects and provide expertise to global project teams
• Manage the preparation and review of global registration packages to ensure compliance with regulatory requirements
• Oversee global submissions and ensure timely compilation and transmission of regulatory documents

Required Qualifications

• BS in Chemistry or equivalent degree
• 10 years of industry experience, with at least 6 years in Regulatory Affairs or CMC regulatory roles
• Experience with global regulatory aspects of CMC across multiple dosage forms
• Knowledge of EU, US, and/or Japan regulations for NCEs and product life cycle maintenance
• Ability to work in a cross-functional and international environment