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Responsibilities
Obtain the regulatory approval timely through the best registration strategy, and maintain product license with local regulation and global compliance standard.
1.Achieve timely registration of new products and their variations/updates
-Prepare and submit registration dossier in accordance with the plan
-Communicate effectively with the Agency, HQ and appropriate experts
2.Support Regulatory Affairs Manager to develop assigned product specific plans and registration strategies
-Analyze regulatory and product information
-Define and anticipate potential issues
3.Maintain product licenses
-Update safety and quality information timely
-Meet the compliance for global RA database
-Follow up post-approval activities(re-examination, DMF, annual report, etc.)
Requirements
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•Functional Knowledge: Drug Development, Local/Global regulatory environment, Structure or functions of pharmaceutical industry
•Skills: Strategic focus,Communication & Negotiation, Project management Skills, Coaching skills, Fluent written & spoken English
•Leadership Behaviors:Commitment/Self-discipline, Make rapid and disciplined decision, Foster collaboration, Build talent, Customer/Quality/Compliance focus
•Education: Pharmacy major is preferred
•Experiences:More than 2years of RA experience(NDA exp is strongly preferred)
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