Regulatory Affairs Officer

+ Provide administrative support within the functional scope.
+ Proceed to apply authorities to get approval for change (if any) related to products/facilities under responsibilities.
+ Manage to ensure validity of all above certificates/licenses
+ Update relevant departments as well as Regional/Global RA for newest updated concerned legal requirements.
+ Coordinate registration orders for 3rd party manufacturers (if any)
+ Approach GRA to be updated all RA issues within the organization.
+ Be responsible to apply and get needed Certificate/License for production / Import / Export of Products, GMP and Manufacturing.
+ Assist in requesting of label, IFU, samples, test reports, raw data and relevant materials from production, sales, SCM.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Yêu cầu công việc

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

Annual Outing Trip
13th month salary payment
Medical Insurance for employee

Cập nhật gần nhất lúc: 2021-12-17 09:22:03