Associate Regulatory Affairs Manager – Abbott Pharmaceuticals (Based In Hanoi) Urgent job

Associate Regulatory Affairs Manager – Abbott Pharmaceuticals (Based In Hanoi)Urgent job

Địa Điểm Làm Việc: Hà Nội
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Các Phúc Lợi Dành Cho Bạn

13 month salary & performance bonus
Premium Healthcare for personal & family
Training

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.
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Yêu Cầu Công Việc

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

Địa Điểm Làm Việc

Hà Nội, Việt Nam

Abbott believes in the power of health. With better health, people and communities can live better and achieve more.
- We create new solutions - in diagnostics, medical devices, nutrition and branded generic pharmaceuticals - that help people around the world, in all stages of life, live their best lives through better health.
- Founded over 130 years ago by Chicago physician Dr. Wallace C. Abbott, Abbott has emerged as one of the largest diversified global health care companies. Our approximately 74,000 colleagues around the globe are devoted to making a lasting impact on human health in the more than 150 countries we serve.
- We believe that good health is not just about treating an illness or managing a medical condition. It’s about supporting people’s health as if it was our own, so they can enjoy all life has to offer. We’ve been focused on helping the people of Vietnam live their best, fullest lives for more than 20 years.

Xem toàn bộ thông tin công ty
02 Ngo Duc Ke, Dist. 1, HCM
1.000-4.999 nhân viên
Talent Acquisition
Bảo Hiểm Sức Khỏe Cho Người Dùng VietnamWorks | Hợp tác cùng Tokio Marine Vietnam

Bảo Hiểm Sức Khỏe Cho Người Dùng VietnamWorks | Hợp tác cùng Tokio Marine Vietnam

Mức phí tốt nhất chỉ từ 600.000 VND/năm

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