Regulatory Affairs Staff

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