Recursion - Director, CMC Regulatory Affairs

• Deep technical knowledge of small molecule drug development • BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 8+ years’ experience in CMC regulatory (both drug product and drug substance). • Extensive command of worldwide CMC regulatory standards and directives for facilitating clinical research, securing international trial approvals, and life-cycle management • Understanding of US and ex-US regulations, providing strategic advice, and supporting cross functional teams in navigating regulatory requirements and implementing change. US, EU and other Ex- US experience is required. • Assess and manage risks for drug development in all regions as applicable • Demonstration of cross-functional understanding and technical team support related to CMC aspects of drug development. • Managing multiple projects and priorities • Demonstrated track record of authoring and producing high quality INDs, IND amendments, NDAs, meeting packages and achieving timelines. US, EU and other Ex-US submission experience is required. • Excellent verbal and written communication skills