Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs

London, England; Oxford, England

Your work will change lives. Including your own.

The Impact You’ll Make

• Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.
• Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings.
• Strategize , plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests.
• Deliver high quality regulatory US, EU and ROW submissions, strategy an...