1. Responsible for ensuring new product registration, regulatory changes, clinical trial applications and labeling changes are carried out in a correct and timely manner
2. Develops and maintains a network with the relevant policy makers and regulatory agencies in Korea
3. Responsible for executing regulatory strategies in Korea, their subsequent implementation and ensuring successful registration to commercialize products
4. Implement appropriate processes and systems to facilitate product registration
5. Responsible for implementing an effective product maintenance and lifecycle managment, in line with legal/regulatory requirements and country business needs
6. Develop and maximize opportunities to expedite the registration process in Korea
7. Implement process for the review and approval of advertising and promotional materials and events(ZINC Maps)
8. Ensure PMS studies are appropriately carried out in a timely manner to fulfill KFDA's requirements
경력 및 자격요건
1. Graduate in pharmacy
2. About 8~10 years experience in managing regulatory function in the pharmaceutical industry
3. Good and broad knowledge of the drug development process
4. Has good knowledge and experience in managing and conducting local and global clinical trials
5. Exceptional command of English
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
