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Regulatory Affairs Specialist
1 month ago
Ensuring necessary compliance with HA, local laws / authorities, for Drugs, Medical Devices, Cosmetics and Food/ Health Supplements
Preparation, Review and Compilation of dossiers for submissions to HA, both offline / online, and following up for status of dossiers / supplements.
Represent clients for all matters relating registrations and audits and communicate with clients within Vietnam for resolving queries / FDA issues.
Ensure upkeep and safe custody of all original documents and records
Stay updated and continuously update internal documentation with reference to guidelines
Meet with clients and present to them the services of the company for VIetnam and other markets.
Ensure that SOPs are complied with and updated.
Đảm bảo tuân thủ cần thiết với HA, luật / cơ quan địa phương, cho Dược phẩm, Thiết bị Y tế, Mỹ phẩm và Thực phẩm/ Thực phẩm bảo vệ sức khỏe
Chuẩn bị, Kiểm tra và Biên soạn hồ sơ cho các lần nộp hồ sơ cho HA, cả trực tuyến và ngoại tuyến, và theo dõi trạng thái của hồ sơ đã nộp/ hồ sơ bổ sung.
Phản hồi các bổ sung / câu hỏi cần thiết, và gặp gỡ với HA để giải quyết câu hỏi, và theo dõi trạng thái của các hồ sơ đăng ký.
Đại diện cho khách hàng trong tất cả các vấn đề liên quan đến đăng ký và kiểm toán và giao tiếp với khách hàng ở Việt Nam để giải quyết các câu hỏi / vấn đề của FDA.
Đảm bảo bảo quản và giữ gìn an toàn tất cả các tài liệu và hồ sơ gốc
Cập nhật liên tục và không ngừng cập nhật tài liệu nội bộ với tham chiếu đến các hướng dẫn
Gặp gỡ với khách hàng và giới thiệu cho họ các dịch vụ của công ty cho Việt Nam và các thị trường khác.
Pay: 12,000,000₫ - 13,000,000₫ per month
**Education**:
- Bachelor's (preferred)
**Experience**:
- Regulatory: 3 years (preferred)