
Quận 10, Hồ Chí Minh
Nghỉ trọn T7, CN
Hạn chót 15/10/2026
Đăng 7 ngày trước
Ít hơn 20 ứng viên
• Degree in Pharmacy or a related discipline • Minimum 5 years of experience in Regulatory Affairs within the healthcare or pharmaceutical industry • Strong knowledge of local regulatory requirements and Health Authority processes in Vietnam • Fluent in English, both written and spoken • Proficient in Microsoft Office applications including Excel, Word, and PowerPoint • Strong communication, time management, and problem-solving skills with the ability to work effectively in a cross-functional team environment
• 3 years of experience in Regulatory Affairs
1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Other responsibilities • Support other tasks assigned by RA management • Cấp bậc: • Loại công việc:
Nếu bạn đang tìm kiếm vị trí Executive Regulatory Affairs (Healthcare) tại Quận 10, Hồ Chí Minh, đây là cơ hội làm việc tại DKSH Vietnam Co., Ltd. với mức lương cạnh tranh và môi trường làm việc chuyên nghiệp. Ngoài tin tuyển dụng này, Upzi còn cập nhật nhiều việc làm cùng lĩnh vực và địa điểm mỗi ngày.
13 payment + Performance bonus
PTI
More enhance training courses
Lương không công khai
Hà Nội, Hồ Chí Minh
Nghỉ trọn T7, CN