Copyright© Sysmex Corporation, All Rights Reserved.
Support clinical sites and their patients
through regulatory application
Regulatory Affairs I.YJoined the company in 2015 New Graduate Biological science system
- Delivering products globally related to my specialized field at university.
- Leading projects which introduce new products into the market.
- Realizing that the results of my daily work have a direct impact on patients.
In the Regulatory Affairs Department, I am responsible for applying for permits in order to expand Sysmex’s product portfolio in each country.
Each country has its own laws and regulations for pharmaceuticals, medical devices, diagnostics, etc., and we are only able to develop products once we have applied for the permits and licenses required for our products in each country and regulatory agencies have recognized their safety and effectiveness. In our daily work, we collaborate with both our development department and overseas subsidiaries to formulate strategies for permit applications, prepare application materials, and negotiate with the authorities, aiming for the early introduction of our products into the market. From my involvement in the product planning stage, I have gained a lot of experience in product development, license application, market introduction, and the entire product life cycle, and my work feels rewarding every day.
Entry - 4th year
Gained experience in the overseas regulatory application of new products in the hematology and urinalysis fields, and the process from domestic regulatory application to insurance application.
5th year - present
Responsible for projects from regulatory strategy planning to regulatory approval for highly novel products related to, for example, malaria, clinical FCM, and genetic testing.
Q. Could you tell me your reasons for joining the company and what you think is good about Sysmex?
The reason is that I wanted to contribute to the global medical field through my pharmaceutical work in clinical testing. At university, I worked on basic research and witnessed the birth of various new technologies in Life Science. However, for new technology to be put into practical use and contribute to the medical field as a product, I realized that a lot of effort is involved for medical professionals, such as clearing the Regulatory Affairs regulations which include the product development process and clinical trials. Based on my expertise, I wanted to be involved in launching new products around the world, and I started to aspire to work in Regulatory Affairs. I think it was quite rare at that time for companies to assign new graduates to regulatory affairs.
I feel that the good thing about Sysmex is that people with various specialties can demonstrate teamwork through discussions. In addition, there is a culture of taking on challenges, such as being entrusted with a big project from a young age. Sometimes they fail, but there is a culture of follow-up and recovery rather than simply blaming people for making mistakes. Because it is a company where people with various specialties come together, there is a culture of respect and listening to the opinions of other professionals in their area of responsibility, regardless of their age or how long they have been in the company.
Q. Could you tell me what's fun about your work?
Since Regulatory Affairs is a department that deals with legal issues, I imagined that I would often have to stare at documents in silence at my desk until I was given the assignment to work on. In reality, I often collaborate with various departments within the company, including overseas subsidiaries, so I have a lot of communication with and get a lot of inspiration from the members around me every day. New product development projects involve various departments such as Development, Marketing, and Quality Assurance. We work together with members from different departments and specialties to decide how best to proceed with our projects. Regulatory Affairs make recommendations on how to ensure the safety and effectiveness of our products and for future regulatory applications, but all project members have the shared goal of launching our products globally at an early stage. I am working on it. Regulatory Affairs can be involved in the entire project from the planning stage of a new product to its introduction to the market, and it is very interesting to see how it’s manufactured.
Q. What kind of relationship do you have with people overseas?
Since Sysmex products are developed with a view to global expansion, the number of overseas regulatory applications is naturally increasing. Under the different regulations in each country, we cooperate with the person in charge of each overseas subsidiary to prepare the necessary information and documents and work on the application. Emails and web conferences with people overseas are common, and due to the time difference, we sometimes have meetings early in the morning or in the evening. Also, depending on my responsibilities, there are opportunities for overseas business trips once or twice a year. It is essential to improve and maintain our English skills as it is necessary for our work. We have a lot of in-house support, and everyone is working on language learning in the way that best suits them.
Other members are currently in charge at the moment, but I also have the task of maintaining product registration after the product is deployed and responding to changes in regulatory regulations. In some cases, we cooperate with the person in charge of the overseas subsidiary to check the latest legal and regulatory status and take necessary measures on-site. Because of the time differences, going directly to the site to concentrate on these things can be more efficient.
Q. Could you tell me about something that has left an impression on you?
Work that involved applying for insurance coverage in Japan for a diagnostic agent for the hematopoietic neoplastic blood cancer disease left an impression on me. Unlike my usual regulatory duties, I worked with a clinician and a member of the Ministry of Health, Labor, and Welfare. As I proceeded with the preparations, I realized that this test was strongly sought after in the actual medical field, which had been waiting for a long time and wanted us to introduce it to the clinical field as soon as possible. Being told that made a big impression on me. I had the valuable experience of actually listening to the voices of people in the medical field, and I became more aware of the people I contribute to. It takes time for our products to reach the market due to the laws and regulations of each country, but this experience reaffirmed that the accumulation of daily regulatory affairs contributes to patients.
Q. Message for anyone wanting to join Sysmex
At Sysmex, I feel that I have the opportunity to take on various challenges based on my expertise. In addition, it is fun and inspirational to move things forward through free and open discussions with members who have diverse specialties and backgrounds.
We are constantly taking on new challenges in the field of clinical testing, so I think it is a perfect company for people who want to grow together with others.
Going to the office
Checking emails and responding to inquiriesCheck emails from overseas subsidiaries. Respond to inquiries from regulatory agencies in each country. Sometimes I also provide bidding item support.
Attending an in-house meetingMeeting about new product development projects. Update my team members on regulatory requirements so that regulatory approval and market introduction can be carried out smoothly in each country.
LunchLunch with my colleagues at a Techno Cafe. When the weather is nice, I take a walk in Techno Park's Japanese garden and relax.
Attending a department meeting and study sessionMeeting in the department. Review the issues pointed out by regulatory agencies and confirm the latest examination trends in each country. We also hold study sessions on the laws and regulations in each country on a rotating basis.
Creating materialCreate regulatory application materials for new products. We work with the development department and members of overseas subsidiaries.
Preparing for meetings and responding to inquiriesPrepare meeting materials for the next day, respond to inquiries from related departments, and carry out legal and regulatory investigations.
Leaving the officePractice with the in-house basketball club once a week. Clear my head and go home.