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13th month salary payment
Medical Insurance for employee
Annual Outing Trip
Mô Tả Công Việc
The job will prepare all applications for the permits, license, certificates, authorization of the organization's products to conduct its business activities. The role will ensure the company regulatory affairs comply with statutory requirements.
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.
Xem toàn bộ 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
- University graduated, major in Pharmacy or Chemistry;
- 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;
- 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;
Địa Điểm Làm Việc
170 Đê la Thành, Đống Đa, Hanoi, Vietnam
