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Global CMC Regulatory Lead for Small Molecules

TechDigital Group, Lawrenceville, New Jersey, United States

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An established industry player is seeking a Regulatory CMC Specialist to join their dynamic team. In this pivotal role, you will participate in the development of regulatory strategies for small molecules and manage CMC activities related to both developmental and commercial compounds. You will prepare and review essential regulatory documents, ensuring compliance with FDA, EMA, and ICH guidelines. Your expertise in drug development processes will be crucial as you represent the Regulatory CMC function on cross-functional teams. If you have a solution-oriented mindset and excellent communication skills, this opportunity is perfect for you to make a significant impact in the regulatory landscape. #J-18808-Ljbffr