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Mô Tả Công Việc
Give impact to RA team to achieve goals. The job holder is responsible to support/monitor the RA team to achieve the goals.
To provide regulatory support in the registration of pharmaceutical and medical devices in B.Braun Vietnam.
This includes to:
+ Be responsible to apply and get needed Certificate/License for production / Import / Export of Products, GMP and Manufacturing.
+ Manage to ensure validity of all above certificates/licenses
+ Proceed to apply authorities to get approval for change (if any) related to products/facilities under responsibilities.
+ Requesting of label, IFU, samples, test reports, raw data and relevant materials from production, sales, SCM.
+ Coordinate registration orders for 3rd party manufacturers (if any)
+ Update relevant departments as well as Regional/Global RA for newest updated concerned legal requirements.
+ Provide administrative support within the functional scope.
+ Approach GRA to be updated all RA issues within the organization.
Yêu Cầu Công Việc
- Having experience & good knowledge in registration activities;
- Working experiences in Pharmaceutical/Medical companies are preferable;
- Good relationship with the authorities related to registration task is preferable;
- Good knowledge and understanding of concerned legal requirement related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration;
- Good command of English;
- Computer literacy;
- Good communication skill, reporting skill, problem – solving skill; analytical skill;
- Able to work individually with less supervision or work in team;
- Careful, honest, high sense of responsibility;