This blog was written before I joined the Regulatory team in my current company. Since then, I have been promoted to the position of a Regulatory Affairs Associate and have gained valuable experience in the department.
This assignment helped me cultivate skills that will be directly transferable to my future role as a Regulatory Affairs Associate. It helped me learn and practice one of the core skills required in Regulatory Affairs, which is putting together a submission in the CTD format – starting with identifying the change proposed, to communicating this change in a letter to the TGA, while supporting it with relevant data and justifications.
Another area I was able to become familiar with was gathering the data that is needed for an application. In my current role in the Quality Assurance department in a pharmaceutical company, I am aware of the huge amounts of data produced in different departments such as Quality Control, Validation, Manufacturing etc. Realising that not all data that is available is needed for every application, identifying the data needed and utilising it to support the proposed change was a very practical aspect of the assignment.
The assignment promoted me to utilise research tools and get into the habit of research. Since most things were new to me and I was trying to understand the submission process, I questioned new terminologies and concepts and researched those so as to get a holistic understanding of the requirements of the assignment as well as to look into the minute details of preparing the application.
Completing this assignment was an educating process. Doing assignments such as these fosters independence and confidence while developing the technical skills required in this field. Although I enjoy working in a group where members bring in different ideas which may help save time to a certain extent, I think this kind of independent study helps me retain the research techniques used and knowledge gained for a longer period of time.
I was able to do tasks that will be an integral function of my future role as a Regulatory Affairs Associate. I was able to identify the submission type; reading and interpreting guidelines available on TGA website helped me familiarize myself with the application process and gain confidence that I would be able to start my new role with the skills gained through doing this assignment.
I appreciated the experience of compiling this assignment for the value that it has added to my skill set. In a nutshell, it was an excellent exercise directly applicable to my new role and in my case, the timing was excellent as well.