www.rednucleus.com contact us at info@rednucleus.com Case Study R&D REGULATORY EXPERT – CMC PHARMACEUTICAL CONSULTANT Client Challenge The client, a global pharmaceutical company, faced challenges in workload when they suddenly lost an internal resource. The client needed immediate support within the regulatory CMC function to assist with various deliverables and tasks. They required an experienced regulatory specialist with knowledge of global regulations and submission types. This person would provide CMC support of the technical CMC section for new products and/or marketed pharmaceutical products worldwide and would have extensive customer interactions with R&D functions, and other teams within Regulatory Affairs. Experience with preparing and editing submissions to include appr

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