Đăng nhập ĐĂNG KÝ

Tìm Công Việc Mơ Ước. Nâng Bước Thành Công!!

Cảm ơn bạn chọn Pharma360Tìm việc

Regulatory Affairs Staff

VPDD Kwan Star Co., Ltd tai Ha Noi

Thỏa thuận
20-09-2021

Kinh nghiệm: 0-2 year

Yêu cầu bằng cấp: Không yêu cầu

Số lượng cần tuyển: 1

Ngành nghề: Duoc si

Địa điểm làm việc: Hà Nội

Chức vụ: Tất cả

Hình thức làm việc: Full time

Yêu cầu giới tính: Nữ

Chi tiết

Job Description
- The coordination and the preparation of registration documents/packages for regulatory submissions as ACTD format (ASEAN Common Technical Dossier) for the products.
- To review and evaluate technical and scientific data and reports required for submission in support of registered products.
- To compile, review, edit and proofread regulatory documentation.
- To work closely with Headquarter’s Regulatory Affair team to obtain complete registration documents for faster product registration in Vietnam.
- To submit an initiative or renewal for the product registration in Vietnam by the optimum utilization of available documents and effective communication with the government reviewers.
- To develop strategy to facilitate the submission and approval of product registration.
- Track of status and progress of regulatory documentation.
- To compile and prepare responses to regulatory authorities’ questions and to maintain regulatory files in a format consistent with requirements.
- To manage MA license (Marketing Authorization) to ensure sustaining business (renewal & change re-registration).
- To maintain awareness of regulatory requirements.
- To support sales team and product specialists related to RA documents to ensure business operation.
Qualification
- Pharmacy Degree holder.
- Meticulous, well organized and attentive to details.
- Excellent in reading and writing English.
- Good at speaking and listening English.
- Familiar with MS Office Application/Internet.
- Proofreading and editing skills.
- Good communication and interpersonal skills, open mind, independent and proactive.
- Detail and result oriented with business sense.
- Willing to learn and take challenge.
- Demonstration of a good team spirit.
- Behavior according to the Kwan Star Leadership Expectations and Vital behaviors.
Gender: Female
Experience: 0-2 years
Probation: 2 months
Working Form: Long-term Staff
Vacation Time & Holidays: In accordance with Labor Law of Vietnam

Please send email to: (Email bị ẩn, Đăng Nhập vào web để nộp hồ sơ)xxx@gmail.com

vui lòng chờ tin đang tải lên

Vui lòng đợi xử lý......

0975 359 386