[KOREA] Regulatory Affairs Specialist (NEW Position)

Location: Seoul, South Korea

Company

hirify.global is a Japan-originated global life sciences company focused exclusively on ophthalmology, developing innovative treatments and digital solutions for eye health.

What you will do

• Prepare Korean NDA applications for new products and variations for approved products.
• Submit applications and responses to the Korean Ministry of Food and Drug Safety (MFDS).
• Evaluate change controls, submission requirements, and expected regulatory timelines.
• Monitor Korean pharmaceutical regulations, guidelines, and directions from the Korean health authority.
• Provide regulatory insights to relevant stakeholders and create compliant Korean product artwork.

Requirements

• Bachelor's degree in Pharmacy is strongly preferred; degrees in Life Sciences or related disciplines are also considered.
• A valid pharmacist license is strongly preferred.
• Fresh graduates, newly licensed pharmacists, and candidates with up to one year of Regulatory Affairs experience are encouraged to apply.
• Basic understanding of Korean pharmaceutical regulations and registration requirements.
• Interest in NDA, variations, K-DMF, and pharmaceutical product lifecycle management.
• Fluency in Korean and English is required.

Nice to have

• Internship, academic, or professional exposure to Regulatory Affairs, Quality, Medical Affairs, or related pharmaceutical functions.

Culture & Benefits

• Inclusive physical and virtual workplace.
• Flexible ways of working.
• Equal opportunity employment and accommodation support during the recruitment process.
• Opportunity to contribute to global ophthalmology initiatives and patient-focused innovation.