Associate Director, CMC Regulatory Affairs

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 essential member of the Recursion Development Team reporting to the Vice President of Regulatory Affairs. The Development Team is an empowered, execution-minded group of development, manufacturing and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities. The Experience You’ll Need - 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 Working Location & Compensation: Making SLC or NYC your home base is ideal; however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events. At Recursion