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- - Planning the best case scenarios of RA plans for NCEs, Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Meeting
- - Establishment of short & long term detailed registration plan and follow up to meet the expected approval timeline
- - Maintenance of good relationship with regulatory authority and internal stakeholders.
- - Timely and appropriate regulatory update of existing products
- - Impact analysis and establishment of strategy according to the amendment of the guidelines
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- 3-10 years of experience in regulatory including the leadership and delivery of a range of regulatory submissions (Vaccines preferred)
- Bachelor¡¯s degree in Pharmacy, Biological, Chemical or life-science related
- Fluent in English speaking, writing and reading
- Knowledge of regulatory agency guidelines and expectations in the submission process
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À̸ÞÀÏ: carly.lee@peoplework.co.kr******@*******.***
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