Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP
Core
Assess regulatory impact of CMC, manufacturing, supply, and labelling changes for clinical trial medicinal products and coordinate implementation across EU/EEA requirements.
Role type
Senior Regulatory Affairs Manager (CMC & Change Control)
Builds
Regulatory change control processes, Summary of Changes (SoC) documentation, and compliant clinical trial submissions
Domain
Life Sciences / Clinical Trials / EU/EEA Regulatory Affairs
Required skills
EU/EEA clinical trial regulations, CMC regulatory assessment, Summary of Changes (SoC) preparation, manufacturing licence management, GMP certificate review, regulatory intelligence, stakeholder coordination, process improvement
Preferred skills
Pharmaceutical manufacturing experience, commercial medicinal products knowledge, client-facing coordination, simplified IMPD authoring
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, manage product-specific and non-product-specific regulatory changes, review and compare revised SmPCs and clinical labels, coordinate regulatory change-control activities, provide regulatory intelligence, support process development and continuous improvement
Seniority
Senior, hands-on IC