Regulatory Affairs Specialist (NDA, Variations, K-DMF)

About the role

Santen Korea, part of the Santen Group, a life sciences company focused on ophthalmology with a presence in over 60 countries, is looking for a Regulatory Affairs Specialist to join its team in Seoul. The role prepares and submits Korean applications for new products and variations, monitors local regulations and provides regulatory insight to colleagues.

Key responsibilities

• Prepare Korean applications for NDA for new products and variations for approved products assigned by the head of RA in SKR, and submit them to the Korean Health Authority (MFDS)
• Respond promptly to requests from the Korean Health Authority by preparing the required documents on time, under the supervision of the head of RA in SKR
• Evaluate change controls and review their requirements and expected schedule, under the supervision of the head of RA in SKR
• Monitor local regulations and guidelines and share them with stakeholders in a timely manner, under the supervision of the head of RA in SKR
• Comply with local regulations and guidelines and give regulatory insights to relevant functional members, under the direction of the head of RA in SKR
• Create local artwork in Korean that complies with local regulations and internal standards
• Monitor new and updated Korean regulations, guidelines and the direction of the Korean Health Authority

Required profile

• Bachelor's degree in Pharmacy with a valid pharmacist license strongly preferred; Life Sciences or related degrees also considered
• Fresh graduates, newly licensed pharmacists and candidates with up to 1 year of Regulatory Affairs experience are encouraged to apply
• Fluency in Korean and English (reading, writing and speaking)
• Previous internship, academic or professional exposure to Regulatory Affairs, Quality, Medical Affairs or related pharmaceutical functions is advantageous

Required skills

• Basic understanding of Korean pharmaceutical regulations and registration requirements preferred
• Interest in regulatory affairs and product registration, including NDA, variations, K-DMF and lifecycle management