Associate Director, CMC Regulatory Affairs

Recursion•Salt Lake City, UT

23h•$176,400 - $228,250•Hybrid

About The Position

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.

Requirements

Deep technical knowledge of small molecule drug development
BA/BS, MS or PhD in relevant technical discipline
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

Nice To Haves

RAC certification preferred

Responsibilities

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.