Quality Senior Manager (Analytical CMC)
Core
Lead author for key Module 3 Common Technical Document (CTD) sections in support of global biologics regulatory submissions.
Role type
Senior Manager, Analytical CMC Regulatory Affairs
Builds
Regulatory submissions (BLAs, MAAs, INDs, IMPDs) for biologics
Domain
Biologics / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Authoring CTD Module 3 sections (S.2, S.4, S.5, S.7), Analytical method validation, Stability study design, cGMP compliance, Global regulatory guidance interpretation, Cross-functional project leadership, Technical data interpretation
Preferred skills
Advanced degree in Chemistry/Physical/Life Sciences/Engineering, Experience in QA/QC/R&D environments
Technologies
Electronic document management systems, Statistical quality systems
Responsibilities
Author and review new applications and amendments for CTD Module 3 sections, Support responses to regulatory questions, Provide subject matter expertise in analytical methods and stability studies, Ensure consistency and compliance of submission documents, Lead cross-functional project meetings, Interact with teams to gather and interpret technical data
Seniority
Senior, hands-on IC with supervisory experience
