Recursion
TechBio
AssociateDirector,CMCRegulatoryAffairs
“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
Applying for this Associate Director, CMC Regulatory Affairs role?
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