Santen
Life Sciences
RASpecialist
“RA Specialist at Santen. Skills: Regulatory affairs, Korean regulations, Pharmaceutical registration. Prepare Korean applications for NDA. Submit application for NDA(s) or variation(s) to Korean”
Industry & Context.
What They're Looking For.
Must Have
Working experience for RA at pharmaceutical company(s) in Korean for more than 3 years, Fluent in Korean and English (Reading, writing and speaking)
Nice to Have
Bachelor degree in Pharmacy, Knowledge of Korean legislation and regulations for pharmaceuticals, Understanding of the registration procedures in Korea for NDA, variations, K-DMF and other regulatory scopes, RA experience in foreign pharmaceutical company(s), Working experiences to register K-NDA and/or variations, Both experiences for NDA and BLA, Experience leading a regulatory project from the beginning
What You'll Do.
Prepare Korean applications for NDA
Submit application for NDA(s) or variation(s) to Korean
Respond to any request of K-HA
Prepare relevant documents to be submitted to HA
Evaluate change controls
Review change control requirements
Monitor local regulations and/or guidelines
Share regulations with relevant stakeholders
Comply with local regulations
Provide regulatory insights to relevant functional members
Create local artworks written in Korean
Monitor new and/or updated KR regulations
Monitor updated guidelines
Monitor updated direction of Korean HA
How You'll Work.
Team & Collaboration
Relevant stakeholders; Relevant functional members
Communication Scope
Reading; Writing; Speaking
Process & Methodology
Regulatory project
Applying for this RA Specialist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on SmartRecruiters
- SmartRecruiters often includes a video screening step — check camera and mic permissions.
- Link your GitHub or portfolio directly in the profile section for technical roles.
- Applications may be reviewed by AI scoring before reaching a recruiter — use keywords from the job description.
ANONYMOUS · UNFILTERED
What do employees actually say about Santen?
Real rants from real employees. Read before you apply.