Your Role

• Achieve the regulatory approval timely through the best registration strategy, and maintain product license with local regulation and global compliance standard, collaboration with local, global cross functions
• Maintain and secure product license in terms of CMC/CDS/etc. according to local regulations/law/guidelines, company strategy and global compliance
• Full compliance for RA system update, packing materials(artwork), promotional materials/activities, drug safety reporting etc
• Achieve new product registration in collaboration with Global team and related local functions (BU, Medical, QA, MA, etc.) to get the best product registration with commercially attractive labelling in accordance with registration plan
• Ensures the product registration application for new marketing authorization, variations such as production site transfer, new indications, etc. are submitted in a timely manner in compliance with internal and external regulatory requirements.
• Monitors the strategic issues that make changes to legislative requirements.
• Monitors the progress of audit and training on management of government licenses. e.g. Importation of pharmaceutical product, wholesaling and importation of medical device
• Ensure the readiness of packaging material reflecting product approval/variation and regulations
• Foster and maintain good relations with internal and external stakeholders
• Support new product registration in collaboration with Global RA and related local functions ( Marketing, Market Access, Medical, etc.) to achieve the best product registration with commercially attractive labelling in accordance with registration plan
• Ensure compliance with promotional material review, KRPIA code of conduct, relevant regulations and laws for related local activities (system update, packing materials, promotional materials/activities, drug safety reporting etc.)

Who You Are

• Bachelor’s Degree in related field
• 1+ years experience of pharmaceutical regulatory experience
• Fluent in Korean, Proficient in English
• Experience in multi-national experience preferred
• Pharmaceutical license is a plus
• Good organizational skills and strong verbal and written communications.

• 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

• 지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다

• (The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)