Role Description Your work will change lives. Including your own. - 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. Qualifications - 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. - 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. - Excellent verbal and written communication skills. Requirements - US, EU and other Ex-US experience is required. Benefits - Estimated current annual base range for this role is $176,400 to $228,250. - Eligible for an annual bonus and equity compensation. - Comprehensive benefits package. Company Description Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London.

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