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, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is
$176,400 to $228,250. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-REMOTE
