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What Does CMC Regulatory Affairs Do?
Manage episode 446369707 series 3603634
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The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, and marketing comply with regulatory standards. The source details the key functions of CMC RA, such as regulatory strategy development, submission management, and compliance monitoring, and highlights the importance of collaboration with various departments, such as research and development, manufacturing, and quality assurance. Additionally, it provides insights into the day-to-day work of CMC RA professionals, emphasizing the need for clear communication, detailed documentation, and a deep understanding of regulatory guidelines. Finally, it emphasizes the human side of CMC RA, encouraging professionalism, courtesy, and cooperation amongst teams.
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