Nhân viên đăng ký thuốc
Địa điểm làm việc: Hà Nội
Chức vụ: Nhân Viên
Hình thức làm việc: Toàn thời gian
Yêu cầu giới tính: Nữ
Yêu cầu
- Pharmacy Degree holder.
- Meticulous, well organized and attentive to details.
- Excellent in reading and writing English.
- Pretty 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.
- Patience and carefulness
- 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.
- Probation: 2 months
Quyền lợi
- Social insurance, Health and unemployment insurance pursuant to Law of Vietnam.
- Receive the 13th month salary
- Vacation time and holidays: in accordance with Labor Law of Vietnam.
Chi tiết
- 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.
- Good health, and to be able to travel to other provinces and oversea.