Associate Regulatory Affairs Manager, Pharmaceuticals Division
Hà Nội
Hạn nộp hồ sơ:
07/11/2026
Về công việc
Trách nhiệm chính
- Plan, direct, and monitor regulatory affairs to secure necessary permits, licenses, certificates, and authorizations for current and future business activities.
- Maintain local SOPs and regulatory policies, ensuring compliance with Vietnam regulatory requirements.
- Serve as primary contact with DAV, MOH, and other regulatory authorities, establishing and maintaining positive relationships.
- Liaise with functional managers to understand business goals and develop plans, cost estimates, and schedules for acquiring necessary permits/approvals.
- Own ultimate accountability for the function, providing advice and recommendations on regulatory compliance.
- Ensure regulatory activities are conducted accurately, ethically, and in accordance with relevant regulations, laws, and standards.
- Assure audits meet organization and government standards.
- Consult with management on related issues.
- Supervise registration of marketed products.
- Monitor and disseminate information on regulatory changes affecting registration, manufacture, distribution, and sale of Abbott products.
- Provide consultation to Operations, QA, and Commercial teams on suitability/acceptability of new product submissions per Vietnam regulatory standards.
- Provide regulatory input and support for marketing plans, product launches, and cross-functional activities.
- Review and approve promotional materials, product information, and labels for regulatory compliance.
- Prepare and maintain local SOPs and policies relevant to Regulatory Affairs.
Yêu cầu
- >7 years experience in regulatory affairs within a pharmaceutical company, with experience leading a team of RA professionals.
- Bachelor's degree in pharmacy; Registered Pharmacist in Vietnam.
- Proficiency in Vietnamese and English.
- Proficiency in MS Office.
Thông tin khác
- Reporting to Regulatory Affairs Manager.
- Working Location: Handi Resco Tower, Kim Ma, Hanoi.
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