职位描述
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工作职责
* 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
* 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
工作地点
地址:北京北京市
求职提示:用人单位发布虚假招聘信息,或以任何名义向求职者收取财物(如体检费、置装费、押金、服装费、培训费、身份证、毕业证等),均涉嫌违法,请求职者务必提高警惕。
职位发布者
拜耳HR
拜耳医药保健有限公司
- 石油·石化·化工
- 200-499人
- 外商独资·外企办事处
- 经济技术开发区
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