Opportunity Description
Job Description
- 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.
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