Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi)

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:
- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution, and sale of Abbott products.
- Assure all audits so that organization and government standards on products/ processes are met.
- 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.
- Supervise the registration of marketed product.
- Consult on ongoing basis on related issues with management team.
- 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.
Support to QA, Manufacturing and Marketing activities:
- 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.
- Provide consultation where needed to Operations, QA and Commercial team on suitability/ acceptability of new product submissions supporting document as per Vietnam regulatory standards.
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.
- Special projects as needed by Management team.

Performance Bonus
Premium Healthcare
Training & Development

Cập nhật gần nhất lúc: 2025-10-17 23:30:03