- Manage registration of new/line extension products, variations to marketed
products to ensure regulatory approvals are achieved in accordance with
Company objectives.
- Coordinate responses to deficiency letters and other requests for data in
agreed timelines
- Prepare safety update reports, certified product details and import permits
- Maintain contact with governmental officials of Korea FDA, NIH, HIRA, MOHW
to facilitate evaluation processes.
- Liaise with operations department and others to maintain product changes and
ensure these comply with regulations.
- Review labeling, product information and promotional materials for compliance
with relevant regulations and codes.
- Provide support for marketing plans and launch teams
- Maintain good knowledge of the relevant Regulations & Code.
지원자격
- 허가, 등록 업무 경력 3~7년
- 제약 및 관련학과 전공자
- Good command of English