Kinh nghiệm: 1 năm
Yêu cầu bằng cấp: Tốt nghiệp đại học Y Dược
Số lượng cần tuyển: 1
Ngành nghề: Đăng ký thuốc
Địa điểm làm việc: Hà Nội
Chức vụ: Nhân Viên
Hình thức làm việc: Fulltime
Yêu cầu giới tính: Nam/Nữ
- Graduated from Pharmacy University
- Careful and self-disciplined.
Knowledge & working experience:
- Knowledge of products development process, eye diseases, ophthalmic products
- At least 01 experience in regulatory field
- Good at English specially translation and writing skills
- Having good office software skills
- Based on company policy
- eLearning training
- Preparing and submitting registration dossiers in comply with MOH’s regulations and Regulatory plan
- Developing artworks for submission and production/redressing
- Handling regulatory administrative tasks
- Supporting Marketing & Market access teams in submission and following up related dossiers with MOH
Building and maintaining good relationship with relevant authorities.
- Preparing new registration, renewal, variation, importation permission and supplement dossiers in comply with manufacturer-based files, regulatory strategy and MOH’s regulations
- Submitting dossiers and following up with MOH as Regulatory plan
- Working with local agency/manufacturer for developing artworks for submission and production/redressing. Conducting artworks proof-reading to ensure accuracy and consistency of the artworks with registered dossiers and MOH’s approved versions. Ensuring no artwork mistake.
- Working with Business affairs team for preparation of Annual Report for submission to MOH as well as documentation for renewal of Company business license in Vietnam
- Submitting and following up promotional material and symposium registration as requested by Marketing team
- Submitting and following up dossiers for brand name/GMP/API listing as requested by Market access team
- Following up and getting hard copies of MOH’s response letters, approval letters, decisions, notification, requirement, regulations, Product licenses (MA), stamped artworks, etc..
- Filling and maintaining regulatory database both in hard copies and softcopy
- Handling other administrative tasks such as notarization, payments, etc..
- Completing relevant trainings of company, authorities, associations
- Handling other tasks as assigned by Regulatory Manager
- Receiving annual performance appraisal by Regulatory Manager of HCM Rep. Office