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Associate Regulatory Affairs Manager - Abbott Pharmaceuticals
Abbott Laboratories. GmbH
Địa điểm làm việc: Hà Nội
Hết hạn: 1 năm trước
- Chi tiết công việc
- Giới thiệu công ty
Vị trí công việc này hiện tại đã hết hạn nộp hồ sơ, bạn có thể tham khảo thêm một số công việc liên quan phía dưới
Mô tả công việc
ROLES & RESPONSIBILITIES
MAIN PURPOSE OF ROLE
• Product registration including new, renewal, variations, special import license, promotional materials...
• Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management...
• Other tasks assigned by the line manager.
MAIN RESPONSIBILITIES
• Contact with DAV, MOH and relevant Authorities:
Liaise with government to ensure regulatory compliances.
Establish and maintain positive relationship with government agencies and other regulatory authorities.
• Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement...) following the regulation. Supervise the registration of marketed product.
• Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
• Understand and share current updates in regulations/new guidelines/circulars published by DAV
• Evaluate and review registration dossiers for administration
• Keep track of registration status, submissions and registration timeline
• Closely follow up the status of application from the time of submission until getting approval
• Support Marketing team in applying advertisement licenses & detail aid material printing permits
• Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
MAIN PURPOSE OF ROLE
• Product registration including new, renewal, variations, special import license, promotional materials...
• Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management...
• Other tasks assigned by the line manager.
MAIN RESPONSIBILITIES
• Contact with DAV, MOH and relevant Authorities:
Liaise with government to ensure regulatory compliances.
Establish and maintain positive relationship with government agencies and other regulatory authorities.
• Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement...) following the regulation. Supervise the registration of marketed product.
• Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
• Understand and share current updates in regulations/new guidelines/circulars published by DAV
• Evaluate and review registration dossiers for administration
• Keep track of registration status, submissions and registration timeline
• Closely follow up the status of application from the time of submission until getting approval
• Support Marketing team in applying advertisement licenses & detail aid material printing permits
• Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
Yêu cầu
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience: more than 3 years experience in Regulatory, prefer pharmaceutical MNC
CORE Skills Required:
Professional Skill
• Time management
• Persuasiveness
• Good in working arrangement, teamwork
• Honest, careful, patient, highly responsible
Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
Computer Skill: MS office
MINIMUM EDUCATION REQUIRED
• Pharmacist/or Bachelor's degree/or Medical Doctor
Work Experience: more than 3 years experience in Regulatory, prefer pharmaceutical MNC
CORE Skills Required:
Professional Skill
• Time management
• Persuasiveness
• Good in working arrangement, teamwork
• Honest, careful, patient, highly responsible
Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
Computer Skill: MS office
MINIMUM EDUCATION REQUIRED
• Pharmacist/or Bachelor's degree/or Medical Doctor
Quyền lợi
13 month salary & Incentive bonus
Premium Healthcare for personal & family
Training
Premium Healthcare for personal & family
Training
Thông tin khác
Ngày Đăng Tuyển
31/08/2023
Cấp Bậc
Trưởng phòng
Ngành Nghề
Y tế/Chăm sóc sức khỏe
Lĩnh vực
Dịch vụ Y tế/Chăm sóc sức khỏe
Kỹ Năng
Regulatory Affair, Product Registration, Pharmaceutical Healthcare
Ngôn Ngữ Trình Bày Hồ Sơ
Tiếng Anh
Thông tin chung
- Ngày hết hạn: 30/09/2023
- Thu nhập: Thương lượng
Giới thiệu công ty
Chúng tôi tạo ra những sản phẩm đột phá - trong chẩn đoán, thiết bị y tế, dinh dưỡng và dược phẩm - để giúp bạn, gia đình và cộng đồng có cuộc sống khỏe mạnh hơn với đầy những tiềm năng vô hạn. Ngày nay, đội ngũ 115.000 nhân viên của chúng tôi đang cùng làm việc để mang lại tác động bền vững đến sức khỏe của người dân tại hơn 160 quốc gia.
Quy mô công ty
Từ 1000 - 5000 nhân viên
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