The most valuable takeaway was gaining a comprehensive understanding of the core concepts and distinct divisions within the broader regulatory affairs umbrella. This highlighted the field's complexity while clarifying specific roles, entry points and documentation requirements unique to each subsector. Ultimately, this foundational knowledge helped me identify specific areas of interest to target for my own professional development and career growth.

This class informed me about the regulatory frameworks for drugs and medical devices, while also highlighting the soft skills that are required for regulatory affairs. Through assignments and resources discussed in the course, I became familiar with the timeline and necessary information required for regulatory filings. Moreover, I learned how regulatory work is done on a global scale, and how this team needs to work with other departments, such as manufacturing and preclinical researchers, in order to succeed.

Some of the most valuable skills I learned was finding information related to regulatory affairs. I really liked how we were encouraged to find information ourselves in each class to complete in class activities. Additionally, I gained a strong appreciation of the regulatory affairs role, I learned the importance of this role in the drug development pipeline and how integrated it is with other verticals in the pharma industry. I had a great learning experience and hope to apply what I learned in my next job.