← DKSH Vietnam Co., Ltd.
Executive Regulatory Affairs (Healthcare)
DKSH Vietnam Co., Ltd. · Hồ Chí Minh
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Nhân viên
Ngành nghề
Ngành nghề khác
Mức lương
Thương lượng
Địa điểm
Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh
Tổng quan
- Regulatory registration and product lifecycle management
- Lead the preparation, review, submission, and maintenance of product registration dossiers in compliance with applicable regulations.
- Develop and execute regulatory strategies for new product registrations, renewals, variations, and post-approval changes.
- Monitor registration timelines and ensure timely approvals from Health Authorities.
- Coordinate responses to regulatory inquiries and deficiency letters to facilitate product approvals.
- Ensure continuous compliance and maintenance of all product licenses and registrations.
- Handle promotional materials:
- Review and approve promotional materials, product advertisements, drug information, and symposium content to ensure compliance with applicable regulations and company policies.
- Provide regulatory guidance to relevant teams on promotional activities.
- Ensure promotional claims are accurate, scientifically supported, and aligned with approved product information.
- Regulatory consulting
- Provide regulatory advice and guidance to clients and internal departments regarding local regulatory requirements and compliance obligations.
- Monitor changes in regulations, guidelines, and industry requirements.
- Assess regulatory impacts on existing products and business operations and provide proactive recommendations.
- Cross-functional collaboration
- Work closely with Supply Chain, Quality Assurance, Medical Affairs, Commercial, Tender and other departments to ensure smooth product importation, distribution, and commercialization.
- Compliance and reporting
- Ensure regulatory compliance across all products and activities.
- Prepare the performance reports to senior management/ clients
- Support inspections, audits, and regulatory compliance activities.
- Maintain accurate and complete regulatory documentation and records.
- Support other tasks assigned by RA management
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