工作職責(zé)



* Responsible for planning and preparing license maintenance strategy. For
new products, regulatory strategy development should be under direction
* Independently responsible for regulatory activities for maintenance of
marketed products, for new products, which should be under direction
* Independently responsible for timely tracking and update the projects
status, closely monitor projects progress, foresee the potential queries of HAs
for assigned products and seek for the feedback from HAs.
* Serve as a primary contact person with HAs for assigned products/projects.
* Responsible for internal communication under supervision
* Participate in a global regulatory team (GRT) and provided local regulatory
input into the global development plan for assigned projects after alignment
with the supervisor
* Take the responsibility for DA review of the assigned products, and may be
assigned other tasks such as SOP/OI Taskforce contribution, RAintelligence and
competitor information etc.
* Ensure the compliance of Company internal Policy/ system/ database/
responsible projects and local regulation compliant behavior
* Take responsibility and ensure getting license strategically to have the
product in china market in the quickest way; maintaining the licenses and to
ensure that the Company complies with the legislations