Associate Regulatory Affairs Manager, Abbott Healthcare Vietnam
TP. Hồ Chí Minh
Hạn nộp hồ sơ:
01/11/2026
Về công việc
Trách nhiệm chính
- Primary contact with DAV, MOH and relevant authorities.
- Liaise with government to ensure regulatory compliances.
- Establish and maintain positive relationships with government agencies and other regulatory authorities.
- Liaise with functional managers to understand short to medium-term business goals and develop plans, cost estimates, schedules for acquiring necessary permits/approvals.
- Own ultimate accountability for the function and provide advice, recommendations on company regulatory compliance.
- Ensure 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.
- Provide consultation to Operations, QA and Commercial team on suitability/acceptability of new product submissions supporting documents 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.
- 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 their growth plans, develop and maintain succession plan, address future staffing issues proactively.
- Manage team’s development throughout the path to achieve goals.
- Ensure team activities comply with Company Business Code of Conduct and all local applicable laws within scope of function responsibility.
Yêu cầu
- More than 7 years experience in regulatory in pharmaceutical company.
- Experience in leading a team of RA professionals.
- Bachelor's Degree in pharmacy.
- Registered Pharmacist in Vietnam.
- 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 handle high levels of pressure and critical decision-making.
- Good relationship building/ networking.
- Work organization & priority management.
- Vietnamese/Tiếng Việt.
- English/Tiếng Anh.
- MS Office.
Thông tin khác
- Reporting to Regulatory Affairs Director.
- Team Management: Yes.
- Working Location: Abbott Healthcare Manufacturing, VSIP 1, Binh Duong.
- Job type: full time.
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