1. Communicate with RCC in liasion with the product development manager to coordinate the provision of registration dossier, CoPP and samples necessary for submission
2. Prepare the application dossier based on provided registration dossier following local requirement
3. Follow up KFDA's queries and answer the deficiency letter on submitted file
4. Coordinate local BE studies with local CRO, SDC and any other relevant departments regarding discussion of BE protocol & BE batch selection before study starts
5. Study management as per local requirement for BE study including TMF documentation as per local regulations, monitoring during the study and final report submissions, etc.
6. Support the launch preparation including NHI price listing, arrangement of country specific packaging materials and quality control test and etc.
7. Ensure allocated products on the market continue to adhere to approved registrations and complete any variations with the regulatory authority
경력 및 자격요건
2~3years of regulatory affairs in the pharmaceutical industry
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5045
cwlim@nterway.com
