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Zoom in Celltrion

We are looking for talented individuals with global potential

Regulatory Affairs

Work toward Celltrion’s success
in the global market

R&D Div. Regulatory Affairs Team Asst.Manger Je Hyun Whang

임상운영팀 임지웅 과장 사진

Please tell us about your job at Celltrion.
My job is to register and manage Celltrion’s products throughout their life cycle from development, approval, and release, to follow-up management. I analyze regulations and the latest industry trends and prepare and submit approval documents following the relevant regulations in each country. I also monitor and manage approval procedures to respond to any additional requirements that come up during the approval procedures.
What are the competencies and qualities required of your position?
One of the most essential competencies required of regulatory affairs (RA) is the ability to communicate logically. You are required to deliver logical messages and communicate with various stakeholders across all stages from development to launch to ensure precise and harmonious collaboration.
Therefore, an RA employee needs to have expert knowledge in the relevant fields and language proficiency, as well as good communication skills.
What was your most memorable episode at work?
The most memorable episode would be the time when I prepared and submitted documents for my first product approval after joining Celltrion. I was so eager to excel at my first task and pushed myself through a highly demanding schedule. However, the process did not succeed because of my poor communication skills at the time.
Do you have any specific goals or visions? If so, what are they?
My goal is to gain more experience and knowledge at Celltrion and become a global pharmaceutical approval expert. To broaden my experience, I study the latest trends and guidelines and ask for advice from my colleagues. Through these efforts, I want to contribute to the company’s growth as well as the advancement of the Korean pharmaceutical industry.
Do you have anything to say to people looking for employment at Celltrion?
The first step is always important, but choosing your first job after graduation might be the single most crucial decision that you ever have to make. As a global biopharmaceutical company, Celltrion provides you with experience and knowledge in all aspects from development, approval, and market release, to supply network development. Celltrion offers unique opportunities for many new experiences and know-how, which will surely boost your career.