RASpecialist

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. * 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 * 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