The Pharmaceutical Affairs position at Chugai Pharmaceutical covers the entire life cycle.

The final barrier for sending a new drug out into the world is the application for approval from the regulatory authority. At Chugai Pharmaceutical, this is the job of the pharmaceutical affairs position, serving as the anchor in a relay race. Hitomi Keo’s aspiration to work in this pharmaceutical affairs position was sparked when she was undertaking a practicum at a hospital pharmacy while studying pharmacy at university. ‘When I interacted with patients, I could see that they were longing for new, more effective drugs. As my desire to deliver safe and secure new drugs to those patients grew, I decided to apply for pharmaceutical affairs positions at pharmaceutical companies that would allow me to fulfill that role.’ Chugai Pharmaceutical drew her interest as a potential employer because of its advanced drug discovery technologies and abundant development pipelines (new drug candidates), due to its unique business model through its strategic alliance with Roche. At the Chugai Pharmaceutical’s company information session, Keo was given an explanation about the pharmaceutical affairs position and found the job very appealing.

‘Knowing that Chugai Pharmaceutical’s pharmaceutical affairs position can contribute to the entire lifecycle from development strategy to post-marketing reviews of drugs, as well as approval applications, I thought that it would be a very rewarding job. I was also attracted by its bold attitude toward taking on new challenges, including being one of the first companies in the industry to engage in the digitalization of new drug approval application documents, so I applied to join Chugai Pharmaceutical.’ Keo became a member of the Regulatory Affairs Department and was assigned to the preparation of eCTD (electronic Common Technical Documents). eCTD are digitized documents for new drug approval applications. Keo’s mission is to prepare the eCTD in accordance with requirements set by the regulatory authorities with certainty.

Assigned to NDA in her second year at the company

Keo says that Chugai Pharmaceutical’s Regulatory Affairs Department gives junior employees the opportunity to shine. In her second year at the company, Keo was entrusted as the lead for a new drug approval application (NDA). ‘These application packages run to tens of thousands of pages. Various divisions, including research, clinical development, pharmaceutical technology, and drug safety, are involved in their preparation, and we move the project forward toward the goal line in close collaboration with the staff from the respective divisions. The task can be quite onerous, because I need to look at the whole picture and coordinate the schedule with the various divisions, but when all the team members come together as a united force to prepare the eCTD and the application is lodged, that is when I truly feel a great sense of achievement.’ In the three years since she joined the company, Keo has already accomplished three NDAs. The most rewarding part of the pharmaceutical affairs position is witnessing that moment when a new drug is approved out in the world. Keo says that, thanks to its abundant development pipelines, Chugai Pharmaceutical allows its employees to gain such experiences from an early stage.

Keo is currently taking on another important task in addition to NDAs with eCTD. That task is to introduce a new system to improve the efficiency of pharmaceutical affairs work. She joined this task team in her second year at the company and since then, she has been actively working on the planning and development of the system. ‘My job is to build a database to share knowledge about drug approval applications that Chugai Pharmaceutical has cultivated to date. Individual divisions can refer to this database, which will make the preparation of the application documents easier. As the database will be used by several thousands of employees in all divisions that are involved in drug development, it will have a massive impact on the company. While racking my brains about what kinds of specifications would make the database easier for employees to use, I am proceeding with its development with a sense of reward in being able to build something new.’

Chugai Pharmaceutical offers a wealth of opportunities.

While she has only been with the company for a few years, Keo works very hard every day in a job that bears great responsibility. One aspiration that she has held since joining the company is to deliver Chugai Pharmaceutical’s innovative drugs to patients even more quickly, and it is this aspiration that serves as her driving force. ‘New drugs for which I have lodged the approval application are released on the market and delivered into the hands of patients. When I saw positive feedback from patients who used those drugs posted on the company’s website, I realized what my work really meant, which made me very happy. Once the new system we are developing is rolled out in divisions that are involved in drug development, the efficiency of approval application package preparation will improve and drug development will be accelerated, which will make it possible to deliver new drugs to patients even more quickly. As I engage in my work, I always keep in mind the thought that all of my work is connected to patients.’

Keo’s career at Chugai Pharmaceutical has only just begun. Going forward, she wants to actively accumulate new experiences in the Regulatory Affairs Department. ‘I am currently in charge of preparing the eCTD for NDAs, but in the future, I hope to take on a position where I can address each newly developed drug one by one and devise strategies for the pharmaceutical affairs function from the early stage of projects. My group is also working with Roche’s pharmaceutical affairs function, and we have information exchanges regularly on topics such as developments in drug regulation and ways to improve the efficiency of application work with digital technologies. If the opportunity arises, I would love to be posted to Roche or to Chugai Pharmaceutical’s subsidiary in the United States and to build my career globally as well. This company offers a vast range of opportunities, and I want to seize those aggressively.’

*The contents of this article, and the divisions that the people featured in this article belonged to and the names of those divisions are current as of the time of the interview.