Recursion
TechBio
AssociateDirector,CMCRegulatoryAffairs
“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
Applying for this Associate Director, CMC Regulatory Affairs role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Recursion?
Real rants from real employees. Read before you apply.