Job Description
Your work will change lives. Including your own.
The Impact You’ll Make
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; GM...