Recursion
TechBio
AssociateDirector,CMCRegulatoryAffairs
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“Associate Director, CMC Regulatory Affairs at Recursion. Skills: CMC regulatory strategy, Drug development, Regulatory submissions. Lead CMC regulatory strategy development. Implement CMC regulatory strategy”
What You'll Achieve.
Achieving timelines
Industry & Context.
Risk mitigation
Commit to regular on-site visits for remote employees
What They're Looking For.
Must Have
Deep technical knowledge of small molecule drug development, 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 CMC regulatory strategy development
Implement CMC regulatory strategy
Influence regulatory strategy
Provide drug substance recommendations
Provide drug product recommendations
Interpret regulatory requirements
Interpret regulatory guidance
Apply best practices for CMC submissions
Strategize CMC submissions
Write CMC submissions
Manage contributors for submissions
Review submission documents
Respond to agency requests
Deliver regulatory submissions
Deliver regulatory strategy
Deliver regulatory advice
Support review of investigational product labels
Support review of protocols
Support review of investigator's brochure
Support clinical trial GMP inspections
Assess risk mitigation plans
Identify risk mitigation plans
Manage multiple projects
How You'll Work.
Team & Collaboration
Attend team meetings; Provide strategic advice to cross-functional teams; Support cross functional teams; Demonstrate cross-functional understanding; Provide technical team support; One Recursion collaboration
Communication Scope
Excellent verbal communication skills; Excellent written communication skills
Process & Methodology
Managing multiple projects, Managing 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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