Regulatory Affairs Executive
Mức lương: Thỏa thuận
Đã hết hạn nộp hồ sơ - 367 lượt xem
Ngày cập nhật: 21/08/2019
Thông Tin Tuyển Dụng
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.
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 ứng viên
- 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;
Quyền lợi được hưởng
- 13th month salary payment
- Medical Insurance for employee
- Annual Outing Trip
- Medical Insurance for employee
- Annual Outing Trip
Cách thức ứng tuyển
Hồ sơ theo yêu cầu của nhà tuyển dụng khi liên hệ trực tiếp
Giới thiệu về công ty
B.BRAUN VIETNAM COMPANY LTD.
170 La Thanh, O Cho Dua Streets, Ha Noi
Người liên hệ: Human Resources Dept
170 La Thanh, O Cho Dua Streets, Ha Noi
Người liên hệ: Human Resources Dept
B. Braun Vietnam is one of the country’s top healthcare companies. It was established in Vietnam in 1992 and backed up by more than 175 years of experience in continuous pioneering and innovative breakthroughs worldwide. Together with its mother company B. Braun Melsungen A.G. and 64 subsidiaries worldwide, B. Braun ...Chi tiết
B. Braun Vietnam is one of the country’s top healthcare companies. It was established in Vietnam in 1992 and backed up by more than 175 years of experience in continuous pioneering and innovative breakthroughs worldwide. Together with its mother company B. Braun Melsungen A.G. and 64 subsidiaries worldwide, B. Braun has been providing world-class products and services to health care professionals. In the year 1990 B. Braun sold its first products in Vietnam via a Singapore exporter. These products consisted of IV solutions and medical disposables. It established the first Representative office in Ho Chi Minh City in 1992, followed by a representative office in Hanoi in 1993, then in Da Nang and Hue in the years after. In 1996, the construction of the first IV solutions factory was started and it was inaugurated in 1997. The factory had the first extension in 1999 and received its first GMP certificate. In 2008, the construction of the first B. Braun IV sets manufacturing plant in Hanoi, Vietnam was started. The factory was inaugurated in 2011 with the total investment of 32.6 Mio. EUR in the new IV set production facilities, making it the largest medical technology complex in Vietnam. B. Braun affirmed its commitment to invest further in Vietnam through the expansion of the current medical plant in Thanh Oai. The expansion includes a 35.5 Mio. EUR medical equipment factory of 8,500sqm, which was completed in the first quarter of 2015, raising the total investment for this plant to 71 Mio. EUR. Further expansion of the factory is planned to be in the beginning of 2017 with the additional investment of USD 100 million. Today, B. Braun Vietnam with a strong and driven sales force and service team, is one of the leading healthcare companies 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. Ẩn chi tiết
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Tìm thêm việc làm
B.BRAUN VIETNAM COMPANY LTD.
Địa chỉ: 170 La Thanh, O Cho Dua Streets, Ha Noi
Quy mô: 1.000-4.999 nhân viên
Việc làm tương tự
Regulatory Affairs Executive
Mức lương: Thỏa thuận | Hạn nộp hồ sơ: Đã hết hạn nộp hồ sơ