KOREA] Regulatory Affairs Specialist - NEW Position

Job Description

What you will do

• Prepare Korean applications for NDA for new products and variations for approved products of Santen Korea allocated by the head of RA in SKR and submit the application for NDA(s) or variation(s) to Korean HA (MFDS).
• Respond to any request of K-HA in a timely manner by preparing relevant documents to be submitted to HA on time under the supervision of the head of RA in SKR.
• Evaluate change controls and review its requirements along with the expected schedule under the supervision of the head of RA in SKR.
• Monitoring local regulations and/or guidelines and sharing them with relevant stakeholders in a timely manner under the supervision of the head of RA in SKR.
• Comply with local regulations, guidelines etc. and provide regulatory insights to relevant functional members under the direction of the head of RA in SKR.
• Create local artworks written in Korean to be complied with local regulation, internal standards etc.
• Monitor new and/or updated KR regulations, guidelines, direction of Korean HA etc.

Qualifications

What you will bring to the role

• Bachelor's degree in Pharmacy and a valid pharmacist license are strongly preferred. Candidates with degrees in Life Sciences or related disciplines will also be considered.
• Fresh graduates, newly licensed pharmacists, and candidates with up to 1 year of Regulatory Affairs experience are encouraged to apply.
• Basic understanding of Korean pharmaceutical regulations and registration requirements is preferred.
• Interest in Regulatory Affairs and pharmaceutical product registration, including NDA, variations, K-DMF, and lifecycle management activities.
• Previous internship, academic, or professional exposure to Regulatory Affairs, Quality, Medical Affairs, or related pharmaceutical functions is advantageous.
• Fluency in Korean and English (reading, writing, and speaking).

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

*Please note that team assignments may be subject to future changes

Please use the attached Resume Format template when you submit the resume.

Submit in 2 languages please. (Korean & English or Korean & Japanese)