Regulatory Affairs Officer

To provide regulatory support in the registration of pharmaceutical and medical devices in B.Braun Vietnam.
The job will prepare all applications for the permits, license, certificates, authorization of the organization&039;s products to conduct its business activities. The role will ensure the company regulatory affairs comply with statutory requirements.
This includes to:
+ Proceed to apply authorities to get approval for change (if any) related to products/facilities under responsibilities.
+ Update relevant departments as well as Regional/Global RA for newest updated concerned legal requirements.
+ Be responsible to apply and get needed Certificate/License for production / Import / Export of Products, GMP and Manufacturing.
+ Approach GRA to be updated all RA issues within the organization.
+ Coordinate registration orders for 3rd party manufacturers (if any)
+ Assist in requesting of label, IFU, samples, test reports, raw data and relevant materials from production, sales, SCM.
+ Manage to ensure validity of all above certificates/licenses
+ Provide administrative support within the functional scope.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

- Good command of English (verbal & written)
- Good communication skills, reporting skills, problem–solving skills; analytical skills;
- Able to work on multiple priorities simultaneously
- Careful, honest, high sense of responsibility;
- University graduated, major in Pharmacy or Chemistry;
- Computer literacy, proficient in Microsoft Office software
- Having 3-5 years of experience & good knowledge in registration activities;
- Able to follow directions and pay attention to details and deadlines
- Able to work individually with less supervision or work in a team;
- Good knowledge and understanding of concerned legal requirements related to product registration for medicinal, medical devices, supplement and infection control products as well as company operational registration;
- Working experiences in Pharmaceutical/Medical companies are preferable;
- Good relationship with the authorities related to the registration task is preferable;

13th month salary payment

Medical Insurance for employee

Annual Outing Trip

Cập nhật gần nhất lúc: 2021-12-02 14:12:03