Stark Pharma
CMC Regulatory Specialist – Hybrid, 12+ Month Contract
Stark Pharma, Chicago, Illinois, United States
A pharmaceutical company is seeking a CMC Regulatory Specialist to support regulatory submission activities, focusing on Chemistry, Manufacturing, and Controls. The role requires 1-2 years of pharmaceutical industry experience with hands-on knowledge in CMC regulatory activities. Responsibilities include authoring Module 3 content for CTD/eCTD submissions and ensuring compliance with ICH guidelines. This position offers a hybrid work model, ideal for candidates with strong communication skills and relevant academic background.
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