RA Specialist - ¿Ü±¹°è Á¦¾à»ç

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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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