[KOREA] Regulatory Affairs Specialist (NEW Position)
HybridSeoul, Seoul, South Korea
Seoul, Seoul, South KoreaHybridFull TimeSenior LevelBachelors DegreePHARMALarge
Full TimeSenior LevelBachelors DegreeLargePHARMA
Job Summary
Prepare Korean NDA applications and variations for Santen products, submitting them to the Korean HA (MFDS) under the supervision of the head of RA in SKR. Respond promptly to K-HA requests by drafting relevant submission documents, evaluate change controls and their schedules, and monitor local regulations to share insights with stakeholders. Create local Korean artworks compliant with regulatory standards and provide regulatory direction to functional members. Bachelor's degree in Pharmacy is preferred, along with 3+ years of RA experience in Korean pharmaceutical companies. Fluency in Korean and English is required.
Required Qualifications
- Bachelor degree in Pharmacy is highly preffered or Life Scicence any related field
- Knowledge of Korean legislation and regulations for pharmaceuticals (preferable for both chemicals and biologics)
- Understanding of the registration procedures in Korea for NDA, variations, K-DMF and other regulatory scopes (preferable for both chemicals and biologics)
- Working experience for RA at pharmaceutical company(s) in Korean for more than 3 years (preferably to have RA experience in foreign pharmaceutical company(s))
- Working experiences to register K-NDA and/or variations (Preferably to have both experiences for NDA and BLA)
- Preferably to have experience leading a regulatory project from the beginning
- Fluent in Korean and English (Reading, writing and speaking)
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