Associate Director CMC Regulatory Affairs

Job Summary

Leading global CMC regulatory initiatives, the full-time Associate Director CMC Regulatory Affairs will develop and execute regulatory strategies for gene therapy projects, collaborating with cross-functional teams and stakeholders while working remotely from anywhere in the US.

Key responsibilities

• Act as the CMC regulatory lead for complex projects and provide expertise in global regulatory strategy
• Manage the preparation and review of global registration packages, ensuring compliance with regulatory requirements
• Oversee global submissions, coordinating with local and global stakeholders to meet established timelines and quality standards

Required qualifications

• BS in Biology or equivalent degree
• 10 years of industry experience with at least 6 years in Regulatory Affairs or CMC regulatory submissions
• Experience with global regulatory aspects of CMC across multiple dosage forms
• Knowledge of EU, US, and/or Japan regulations for new chemical entities and product lifecycle maintenance
• Demonstrated track record of successful interactions with health authorities related to CMC submissions