Director, CMC Regulatory Affairs

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 and advice. - Support review of investigational product labels, protocols, inve