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Reg Affairs Spec I

Req #: 170008YL_en
Location: Shanghai, 31 CN
Job Category: Regulatory Affairs
Date Posted: 11/3/2017 6:27:04 PM
Baxter International

Responsibilities:

Ø  Prepare & submit documents, deliver timetable for license granted.

Ø  Responsible for license maintenance including renewal, variation, PI, label etc.

Ø  Responsible for IVINA project.

Ø  Responsible for registration affaires of exported product.

Ø  Responsible for regulatory collection, analysis and implementation.

Ø  Support site audit

Ø  Responsible for variation assessment from plant (leverage Trackwise 8 when possible)

Ø  Support other departments such as bidding, market, PV etc.

Ø  Responsible for archiving registration dossiers(leverage BaxEdge or sharepoint)

Ø  Responsible for other tasks assigned by supervisor above and support GRA CMC related tasks

Ø  Develop and improve good relationship with the authorities and promote Baxter image.

Requirements:

Ø  Bachelor degree in pharmaceutical, chemistry, biological and related discipline.

Ø  At least 5 years working experience in a pharmaceutical company and at least 3 years pharm registration experience.

Ø  Be able to project implementation, can face challenge 

Ø  Good communication skill, creative thinking, with teamwork spirit, 

Ø  Good at English writing, reading and speaking.

Ø  Good Computer skill.

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