Reg Affairs Spec I
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.
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.