Senior Regulatory CMC Consultant

About this job

The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness Missions Lead the global Regulatory CMC strategy and support Marketing Authorization Applications Lead/review Module 3 preparation and submission activities Support interactions with FDA, EMA and other Health Authorities, including responses to questions Identify regulatory risks and define appropriate mitigation strategies Operate effectively within a global and cross-functional matrix environment Ensure alignment of CMC regulatory strategies with overall development and commercialization objectives…

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