interview 03
Manager
Regulatory Affairs
As a new graduate, I got involved in formulation design of prescription drugs as a researcher. In its process for new drugs, I had opportunities to interact with colleagues of Regulatory Affairs in a meeting etc.
Even if we are able to develop final drug products, they can be sold only after we obtain regulatory approval by the health authority. So, I have been thinking that I need to experience jobs of Regulatory Affairs to come to grasp an entire process.
It was triggered by the launch of new drug developed in-house that I moved to other company as my next career step to work in Regulatory Affairs.
Although I learned the basics of Regulatory Affairs in that company, I began to feel that there would be no more room to grow myself, because the products for which the company held marketing authorization were limited. That was the time when I was scouted for LTL Pharma.
I thought that I could not make a leap forward unless I gain more experience in Regulatory Affairs, therefore I decided to join LTL Pharma. I thought that I could further develop my career by leveraging own experiences because LTL Pharma, specializing in long-listed products, intended to increase acquisition of products. The company’s direction was in line with what I had been doing till then.
I knew of the company name before I joined but honestly did not understand much about the company due to a paucity of information on its website.
In fact, I saw before a direct mail of Pharmaceutical Association about a switchover of package insert following the instruction of new description. I found a leaflet of LTL Pharma enclosed in it. I had a good impression of the company doing business properly.
After joining the company, I noticed that all departments were staffed with professionals and particularly those of Quality Assurance were highly skilled. There was no gap in my image before and after joining the company.
Since I was told that the company was recently established and staffed with personnel coming from various companies, I was wondering how that impacted unification of directions to perform duties. As it turns out, I found that my concern was pointless, and I feel comfortable in performing tasks.
I take charge of maintaining the licenses and approval dossiers, in relation to them, GMP compliance inspections, responding to the regulatory authorities, and checking of package inserts and product packages from a regulatory point of view.
No work in Regulatory Affairs is exactly the same or repetition of the past since every one of them is different even if you have had experiences in the same matter before. I always make a discovery when carrying out duties.
For instance, GMP compliance inspections yield different results depending on inspectors. Although I have not experienced that at LTL Pharma yet, I discovered something new every time when I responded to inquiries from PMDA about the partial change applications, and I felt tense as their request was different every time.
This is challenging but rewarding especially when my tactful ideas bear fruit, giving me a sense of accomplishment as well as improvement.
We are now in a process of introducing the management system of approval dossiers. I feel that I am playing a part in creating a new company, and it is a worthwhile job.
Coming from a variety of companies, each of staffs brings an advantage individually. It would be wonderful if unique culture as LTL Pharma’s is nurtured.
I once read in an article written by a person from a leading pharmaceutical company, and I remember that the person said, “There is a trend where leading pharmaceutical companies divest products developed and marketed by themselves to other companies. I am worried about, for example, technical transfer in such cases.”
As a person working in Regulatory Affairs, I would like to systematically manage regulatory procedures for transfer of marketing authorization from other companies.
