Associate Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi)

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 Glomed business, ensuring compliance to current Vietnam regulatory requirement.
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.