Associate Director, CMC Regulatory Affairs

Job description

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, investigator’s brochure, and other clinical trial materials; GMP inspections as needed. - Assess and identify on an ongoing basis, risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance. The Team You’ll Join: As Manager/Director CMC Regulatory Affairs you will be an essen...