- 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.
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- Good command of English