Việc làm GSK
Tìm thấy 0 việc làm đang tuyển dụng
GSK
Đã xác minh
Regulatory Affairs Manager
Tweet
Facebook
Copy Link
Thông tin cơ bản
Mức lương:
Thỏa thuận
Chức vụ:
Trưởng phòng
Ngày đăng tuyển:
10/01/2024
Hạn nộp hồ sơ:
09/02/2024
Hình thức:
Toàn thời gian
Kinh nghiệm:
Không yêu cầu
Số lượng:
1
Giới tính:
Không yêu cầu
Nghề nghiệp
Ngành
Địa điểm làm việc
- Tòa nhà Corner Stone Building, Phan Chu Trinh, Hoàn Kiếm, Hà Nội, Việt Nam
Các Phúc Lợi Dành Cho Bạn
International training opportunities
Laptop for each employee
All local legal required benefits container
Mô Tả Công Việc
- Planning and managing registration of assigned products
• To ensure that all new products are registered within the time-frame upon the launching schedule of commercial
• To ensure that renewals of the existing products are obtained timely for the supply continuity.
• To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation.
• To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information.
- Regulatory consultation:
• To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country.
- Risk management:
• Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives.
- Process improvements:
• Continuously review and make the appropriate changes in order to improve the internal and cross-functional process.
- QMS compliance and GSK policies.
- Others: Perform of CMC variation (Vx), Vx Advocacy
• To ensure that all new products are registered within the time-frame upon the launching schedule of commercial
• To ensure that renewals of the existing products are obtained timely for the supply continuity.
• To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation.
• To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information.
- Regulatory consultation:
• To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country.
- Risk management:
• Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives.
- Process improvements:
• Continuously review and make the appropriate changes in order to improve the internal and cross-functional process.
- QMS compliance and GSK policies.
- Others: Perform of CMC variation (Vx), Vx Advocacy
Yêu Cầu Công Việc
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
• Bachelor
• Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
• Taking charge of registration of vaccines, pharma products: building plan for registration, communicating with liaison and CMC team to get appropriate documents as well as finding the best solution, following up progress of dossier assessment, developing artwork and keeping regulatory system updated.
• Collaborating with Marketing to build strategy for vaccine and new products (NCEs)
• Supporting local vaccine release (providing documents, cold chain system, solving issues related to vaccine release in Vietnam) and supply activities
• Updating drug legislation
• In-depth knowledge of vaccines and pharmaceutical products and regulation.
• Experience at least 05 years in regulatory work and environment.
• Regulatory Technical Skills
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
• List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
We are looking for professionals with these required skills to achieve our goals:
• Bachelor
• Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
• Taking charge of registration of vaccines, pharma products: building plan for registration, communicating with liaison and CMC team to get appropriate documents as well as finding the best solution, following up progress of dossier assessment, developing artwork and keeping regulatory system updated.
• Collaborating with Marketing to build strategy for vaccine and new products (NCEs)
• Supporting local vaccine release (providing documents, cold chain system, solving issues related to vaccine release in Vietnam) and supply activities
• Updating drug legislation
• In-depth knowledge of vaccines and pharmaceutical products and regulation.
• Experience at least 05 years in regulatory work and environment.
• Regulatory Technical Skills
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
• List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
Khu vực
Quy mô:
500 - 1.000 nhân viên
Địa điểm:
Phòng 702 và 703, Tầng 7, Tòa nhà Metropolitan Tower, số 235 đường Đồng Khởi, Phường Bến Nghé, Quận 1, Thành phố Hồ Chí Minh, Việt Nam
Ở Việt Nam công ty GSK có nhiều chi nhánh tại Hà Nội, TP.HCM và các tỉnh thành khác.Với tiêu chí đặt bệnh nhân lên vị trí hàng đầu, các chuyên gia không ngừng tìm tòi và phát minh ra những thành tựu khoa học mới, và áp dụng chúng để tạo ra những thuốc, sản phẩm chất lượng nhất phục vụ cho người bệnh. GSK có mặt và đầu tư vào thị trường Việt Nam từ rất sớm, từ đó đến nay đã phát triển thành hệ thống chi nhánh rộng lớn khắp cả nước, góp phần nâng cao sức khỏe và phục vụ tốt nhất cho người dân Việt Nam.
Bạn làm việc tại GSK? Chia sẻ kinh nghiệm của bạn
GSK
Click để đánh giá