The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
What Does CMC Regulatory Affairs Do?
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.