Regulatory Affairs Specialist

• To set registration plan, to perform product registration in accordance with registration and launch plan, & maintain product license with local regulation and global compliance strategy • Review new projects and aset development plan (timeline etc.) in collaboration with Global DRA and related CPO functions (Marketing, HE&P and CD&MA etc.) • Achieve the best product registration with commercially attractive labelling in accordance with registration plan • Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance • Perform IND application & get approval to ensure study timeline in collaboration with medical team and Global DRA • Ensure compliance with NP4, KRPIA code of conduct, relevant regulations, and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) • Develop and maintain good relations with internal and external partners.

• Preferably 2-3 years of experience in the pharmaceutical industry in a relevant field such as regulatory affairs, registration, or a directly related area • Languages: Good command in English (speaking and writing) • Good Interpersonal skills • Strong Project Management • Ability to work under pressure

• Korea pharmacist license is preferred

For more details, please refer to the company website.