Regulatory Affairs Manager
(*) Tin tổng hợp từ nguồn khác, công ty đang được xác thực. Là đơn vị tuyển dụng và muốn chỉnh sửa hoặc gỡ tin này? Liên hệ qua mục «Hỗ trợ» ở cuối trang.
Product Registration & Portfolio Lifecycle Management:
• Lead end-to-end registration, post-approval variations, license renewals, and withdrawals for a diverse portfolio including General Foods, Health Supplements, OTC Drugs, Generics, and Medical Devices.
• Ensure full compliance of all regulatory dossiers with updated national frameworks and local guidelines.
Authority Engagement & Liaison:
• Act as the primary point of contact with key government agencies, including VFA, DAV, FSA, NPRA, MDA, and related health authorities.
• Proactively track submission statuses, address official queries/deficiencies, and expedite application approvals.
Strategic Planning & External Collaboration:
• Partner with internal stakeholders, Managing Director, and RA Lead to formulate regulatory strategies for new product introductions and regional expansion.
• Coordinate effectively with external stakeholders (consultants, CMOs/manufacturers, testing labs, and distributors) to keep regulatory milestones on track.
Operational & Management Support:
• Participate in regulatory meetings, briefings, and audits; provide actionable insights for executive decision-making.
• Execute additional tasks and ad-hoc projects assigned by Executive Leadership and RA Management.
Education: Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Food Science, Life Sciences, or a related field.Experience: 5–6 years of hands-on Regulatory Affairs experience spanning food/supplements, pharmaceuticals, or medical devices.Regulatory Expertise:
• Proven expertise in Vietnamese regulatory frameworks.
• Hands-on familiarity with submission portals and procedures under DAV, VFA, NPRA, and MDA.
Key Skills:
• Proficiency in written and spoken English and Vietnamese.
• Strong project management skills with the ability to handle multiple priorities and strict deadlines independently.
• High analytical accuracy, sharp communication, and strong strategic thinking skills.
13-month salary, Performance Bonus, Annual Leave, etc.
- Giới tính: Không yêu cầu
- Độ tuổi: Không giới hạn tuổi
- Thời gian làm việc: Thoả thuận
- Lương: Cạnh tranh
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