RESPONSIBILITIES:

+ Set up regulatory strategy, product registration timeline and ensure well implement.
+ Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines.
+ Responsible for CTA applications, line extension, license renewal, variation applications (such as CMC changes, safety updates, local repackaging, specification upgrades etc.), including establish the filing strategy, source documents collection and application dossiers preparation, filing and following communications, follow the regulatory progress.
+ Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
+ Develop and maintain tracking system for registration procedure to ensure clear registration status.
+ Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.