Regulatory Affairs CMC Lead

Job Summary

To lead global CMC regulatory strategies for gene therapy products, the full-time Regulatory Affairs CMC Lead will manage complex regulatory submissions and collaborate with cross-functional teams, 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 to ensure compliance with regulatory requirements
• Oversee global submissions and ensure timely compilation and transmission of regulatory documents

Required qualifications:

• BS in Biology or equivalent degree
• 10 years of industry experience in pharmaceutical companies or CROs, 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 and guidelines for NCEs and product lifecycle maintenance
• Fluency in written and spoken English