Associate Regulatory Affairs Manager, Abbott Healthcare Vietnam

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 Director
• Team Management: Yes
• Working Location: Abbott Healthcare Manufacturing, VSIP 1, Binh Duong

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. 

SUPERVISORY RESPONSIBILITIES

• 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.

SUPERVISORY RESPONSIBILITIES

• People Management:
• 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.

• Cấp bậc: Quản lý • Loại công việc: Toàn thời gian