Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP

About this job

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products. This highly client-facing position combines EU/EEA regulatory assessment, CMC and labelling expertise, regulatory change control, Summary of Changes preparation, regulatory intelligence and cross-functional coordination. Strong CMC expertise is essential; however, the primary focus is broader than CMC authoring. The role will assess proposed changes, determine regulatory impact, coordinate implementation activities and support the development of effective processes and ways of working.…

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