As part of this assignment, I was able to take an important work procedure and reorganize, update, and reformat the document. The document I chose was my company’s Regulatory Affairs Procedure. When I started this assignment, I had just begun my position as a Regulatory Affairs Associate and this assignment gave me an opportunity to integrate my professional and academic life into one assignment.
This document’s target audience was the Regulatory and Quality teams at the company I worked for at the time as well as future auditors. This document required me to have an understanding of it’s intention and purpose before I could make the updates required. This procedure laid out the different responsibilities for regulatory compliance at the company, how the company addresses adverse event reporting, and other regulatory related activities. Because I was new to this department, many of the sections were like a foreign language and I didn’t understand their significance. It took several days of reading the document, searching the web for more information, and asking my manager dozens of questions before I reached a point where I felt comfortable making updates. Some of the simple updates included reformatting tables, correcting numbered lists, and addressing misalignment issues. The more difficult updates were verifying references to international standards and removing outdated standards, correcting processes for compliance with specific countries due to regional standard updates and comparing the document to European regulations to ensure it meets specific requirements laid out in that regulation.
This document revision required collaboration with my manager, the Quality Compliance team who would enforce this policy, the change control team at my company who would route this document for approval and implement the document, and my professor who first had to give me approval to use this document for the assignment and provide me feedback. This assignment was the most collaborative focused assignments I have worked on for school. Because there were so many people involved in the process of getting this document approved, I really had to be careful that I had captured everything each person and/or department required, that the language we chose was correct, and that it didn’t increase any audit risks for the future.