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Sr. Regulatory Specialist |
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- 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 |
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~ 11. 9. 25 ±îÁö |
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02-597-1780 |
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[Á¢¼ö¹æ¹ý] E-mail : jiko01@kohuman.com (À̸ÞÀÏ Á¢¼ö¸¸ °¡´É) |
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