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- Registraiton of NCE and new biologics
- Maintenance of product license including registration variation
- Preparation of CTA dossier and getting approval
- Update of labeling including CDS update
- Follow up of regulation change
- Archive and report regulatory activities and documents
- Appropriate communication with internal/external dept. for proper registration of products in Korea
- Review of promotional material and package
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- Graduate from 4 year medical science related university including Pharmacy and Medicine
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- At least 3-5 years experience in regulatory affairs (Must)
- Preferred fluent in English speaking, writing and reading
- Communication skills and presentation skills related to registration, Negotiation skill with investigators
and officers, Medical/regulatory writing and speaking
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