Recursion
TechBio
AssociateDirector,CMCRegulatoryAffairs
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“Associate Director, CMC Regulatory Affairs at Recursion. Skills: CMC regulatory strategy, Drug development, Regulatory affairs. Lead development and implementation of CMC regulatory strategy. Influence regulatory strategy”
Industry & Context.
Commit to regular on-site visits for routine work and departmental events
What They're Looking For.
Must Have
BAS, MS or PhD in relevant technical, 8+ years’ experience in CMC regulatory (both drug product and drug substance), Extensive command of worldwide CMC regulatory standards and directives, Understanding of US and ex-US regulations, US, EU and other Ex- US experience is required, 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
Nice to Have
RAC certification preferred
What You'll Do.
Lead development and implementation of CMC regulatory strategy
Influence regulatory strategy
Provide drug substance or drug product recommendations
Review region specific submission documents
Deliver high quality regulatory submissions
Support review of investigational product labels
Assess and identify risk mitigation plans
How You'll Work.
Team & Collaboration
Attending team meetings; Supporting cross functional teams
Communication Scope
Excellent verbal and written communication skills
Process & Methodology
Managing multiple projects and priorities
Full Job 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 regulation
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