Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP
Core
Client-dedicated Regulatory Affairs Manager assessing EU/EEA regulatory impact of CMC, manufacturing, supply, and labelling changes for clinical trial medicinal products.
Role type
Senior IC Regulatory Affairs Manager (CMC & Change Control)
Builds
Regulatory change assessments, Summary of Changes (SoC) documentation, and updated clinical trial regulatory submissions.
Domain
Life Sciences / Clinical Trials / EU/EEA Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU/EEA clinical trial regulatory assessment, CMC regulatory documentation review, substantiality assessment, regulatory change control coordination, process improvement, stakeholder coordination
Preferred skills
Pharmaceutical manufacturing experience, commercial medicinal products knowledge, quality documentation expertise, direct client interaction
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Perform EU/EEA regulatory assessments of changes, assess impact of CMC/manufacturing/supply/labelling changes, prepare Summary of Changes documentation, coordinate regulatory change-control activities, review and compare revised SmPCs and clinical labels, provide CMC regulatory expertise and support authoring, support EU Clinical Trials Regulation submissions
Seniority
Senior, hands-on IC