Teams at Santen

Prepare and submit Korean NDA and variation applications to the MFDS, respond to agency requests, evaluate change controls, monitor and communicate Korean regulatory updates, provide regulatory guidance, and create Korea-compliant local artworks under the supervision of the Head of RA (Santen Korea).

Lead pharmacoepidemiology and global safety strategy for marketed and development products. Oversee signal detection, benefit-risk evaluations, safety documents (RMP, PSUR, DSUR, CCDS), post-marketing studies, SOPs, GSVEM coordination, publications, audits and cross-functional global stakeholder collaboration.

Lead strategic marketing and product management for ophthalmology therapeutics: conduct market research and competitive analysis, define segments and positioning, manage product lifecycle and indication expansions, execute integrated campaigns, achieve financial KPIs, and build stakeholder relationships with HCPs, KOLs, patient groups, and regulators.