Associate Regulatory Affairs Manager, Pharmaceuticals Division
Hạn nộp hồ sơ: 26/11/2026 (Còn 29 ngày)
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JOB DESCRIPTION
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
MAIN PURPOSE OF ROLE:
- Plan, direct, and monitor regulatory affairs so that the organization has the permits, license, certificate, authorization, and other approvals it needs to conduct its current and future business activities.
- Maintain local SOPs and Regulatory policies and provide support to Abbott Healthcare business, ensuring compliance to current Vietnam regulatory requirement.
- Reporting to Regulatory Affairs Manager
- Working Location: Handi Resco Tower, Kim Ma, Hanoi
MAIN RESPONSIBILITIES:
Primary 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.
Regulatory affairs' key focuses:
- Liaise with functional managers to understand their short to medium-term business goals (for example introducing a new product, service, operating process, entering a new market) and develop plans, cost estimates, schedules for acquiring the necessary permits/ approvals.
- Owns ultimate accountability for the function and provide advice, recommendations on company regulatory compliance.
- Ensure the organization regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations/ laws and standards.
- Assure all audits so that organization and government standards on products/ processes are met.
- Consult on ongoing basis on related issues with management team.
- Supervise the registration of marketed product.
- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution, and sale of Abbott products.
Support to QA, Manufacturing and Marketing activities:
- Provide consultation where needed to Operations, QA and Commercial team on suitability/ acceptability of new product submissions supporting document as per Vietnam regulatory standards.
- Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.
- Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.
- Local SOPs and policies:
- Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs & policies and DAV and VN MOH requirements.
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience
>7 years' experience in Regulatory in pharmaceutical company. Experience in leading a team of RA professionals
Education
Field of Study-Qualification
Bachelor
- Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam.
CORE Skills Required
Professional Skill
Technical skills required for role
- Ability to handle high levels of pressure and critical decision-making
- Good leadership, interpersonal, teambuilding, and problem-solving skills
- Skilled communicator with well-developed verbal, written and presentation ability
- Strategic thinking
- Planning, Organizing and Coordination
- Ability to learn
- Good Relationship building/ Networking
- Work organization & Priority management
Behavioral / Leadership Skill
Apply Abbott Capabilities Framework
Language Skill
- Vietnamese/ Tiếng Việt
- English/Tiếng Anh
Computer Skill
(any specific Computer Skill required)
- MS Office
Thông tin chung
- Thu nhập: Thỏa thuận
Việc làm tương tự khác
VIỆN DƯỠNG LÃO PHƯƠNG ĐÔNG ASAHI - CHI NHÁNH CÔNG TY TNHH TỔ HỢP Y TẾ PHƯƠNG ĐÔNG
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9 - 13 Triệu VND
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Hà Nội, Hưng Yên
20 - 30 Triệu VND
Công ty TNHH Dịch vụ và Thương Mại OZOVN
Hà Nội
15 - 50 triệu VNĐ
Công ty Cổ phần Dược phẩm Gia Nguyễn
Hà Nội, Bắc Ninh, Khác
9 triệu - 13 triệu
Abbott Laboratories. GmbH
- Địa chỉ công ty: Tầng 8, 2 Ngô Đức Kế, Bến Nghé, Quận 1, Hồ Chí Minh
- Quy mô: Từ 1000 - 5000 nhân viên
- Lĩnh vực: Y tế - Dược, Kinh doanh, Chăm sóc sức khỏe
Thông tin công việc
Vị trí:
Nhân viên
Hình thức làm việc:
Toàn thời gian
Việc làm tương tự
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