Regulatory Affairs Officer

+ Be responsible to apply and get needed Certificate/License for production / Import / Export of Products, GMP and Manufacturing.
+ 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.
+ Provide administrative support within the functional scope.
+ Approach GRA to be updated all RA issues within the organization.
+ Manage to ensure validity of all above certificates/licenses
+ 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.

Yêu cầu công việc

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

- Bonus by individual ability and company’s performance.
- Social insurance, health insurance, unemployment insurance and other benefits
- Salary and position is reviewed 1 tame a year
- Company trip once a year + Joining party
- Dynamic and sociable working environment.
- Having chances to get attractive company bonus every month/year

Cập nhật gần nhất lúc: 2021-11-16 10:32:03