Regulatory Affairs Officer/ Executive

Địa Điểm Làm Việc: Hà Nội
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Các Phúc Lợi Dành Cho Bạn

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

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;

Địa Điểm Làm Việc

170 Đê la Thành, Đống Đa, Hanoi, Vietnam
Xem toàn bộ hồ sơ công ty

B. Braun Vietnam, established in Vietnam in 1992 and backed up by more than 175 years of experience in continuous pioneering and innovative breakthroughs worldwide from its mother company B. Braun Melsungen A.G., is one of the country’s top healthcare companies. Together with more than other 60 subsidiaries worldwide, B. Braun Vietnam with a strong and driven sales force and service team, is almost a one-stop healthcare company offering and pioneering in quality and cutting-edge health care products such as infusion solutions and devices, IV cannula, sutures, surgical instruments, diabetes care, out patient market products, value added drugs, regional anesthesia and clinical nutrition.
B. Braun draws its innovative strength from the guiding principle “Sharing Expertise” which cultivates the exchange of information and experience both within the company and more importantly, with practitioners in the hospitals. “Sharing Expertise” is the promise that holds true for B. Braun employees and their customers.

Xem toàn bộ thông tin công ty
170 Duong La Thanh, Dong-Da, Hanoi
500-999 nhân viên
Human Resources Dept
TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC NICE SOPHIA ANTIPOLIS (PHÁP)

TUYỂN SINH THẠC SĨ QUẢN TRỊ THƯƠNG MẠI QUỐC TẾ - ĐẠI HỌC NICE SOPHIA ANTIPOLIS (PHÁP)

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Bằng được công nhận bởi Bộ GD&ĐT Việt Nam do Đại học Nice – Sophia Antipolis (Pháp) cấp có giá trị toàn cầu.

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