Global CMC Regulatory Lead – Biologics

A leading biopharmaceutical company is seeking an experienced Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics. This role involves authoring CMC sections of INDs and BLAs, ensuring regulatory compliance, and leading cross-functional teams to support health authority interactions. The ideal candidate will have a PhD or advanced degree in a relevant field and over 8 years of regulatory affairs experience, particularly in CMC. Strong communication and project management skills are essential.
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