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Associate Regulatory Affairs Manager, Abbott Healthcare Vietnam

Abbott · Bình Dương
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Trưởng / Phó phòng
Ngành nghề
Ngành nghề khác
Mức lương
Thương lượng
Địa điểm
Bình Dương, Bình Dương, Bình Dương

Tổng quan

  • 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 Director
  • Team Management: Yes
  • Working Location: Abbott Healthcare Manufacturing, VSIP 1, Binh Duong
  • 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.
  • Support employees in implementing of their growth plans. Develop and maintain succession plan and address future staffing issues in a proactive manner.
  • Manage team’s development throughout the path to achieve goals.
  • Ensure team activities to comply with Company Business Code of Conduct and all local applicable laws within scope of function responsibility.
  • People Management:

Quyền lợi

  • 13-month salary & performance bonus
  • Premium Healthcare
  • Training & Development
Chế độ thưởngChăm sóc sức khỏeĐào tạo

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