Regulatory Affairs Officer/Specialist

Role Expectations
The Regulatory Affairs Officer/Specialist is expected to ensure full regulatory compliance and timely product registration in alignment with local and global strategies. They need to proactively monitor regulatory changes, propose proper solutions, maintain effective communication with authorities and strong cross- functional collaboration to support business.
Main Responsibilities
- Prepare, review, and submit oncology and other drug registration dossiers in compliance with Vietnamese regulations.
- Monitor dossier progress, respond to inquiries, and prepare justifications for authority requests to ensure timely and accurate submissions of new drug applications, amendments, supplements.
- Coordinate with cross- functional teams (Worldwide & regional RA, manufacturers and other departments).
- Keep updated with the latest pharmaceutical regulations in Vietnam and guidelines.
- Ensure compliance with national and industry- specific regulations. Interpret new rules and implement them throughout the company by updating policies and procedures.
- Handle post- approval activities such as renewal, variation, and dossier updates.

Đào tạo bài bản về nghiệp vụ, kĩ năng, sản phẩm và các kĩ năng khác phục vụ công việc. Tham gia các khoá đào tạo và dự các kỳ họp toàn công ty trong và ngoài nước (Cycle meeting, NC, ...)
Lương cạnh tranh, lộ trình thăng tiến rõ ràng..
Year- end party, Câu lạc bộ bóng đá, cầu lông, và các chương trình internal cực kì hấp dẫn khác

Cập nhật gần nhất lúc: 2025-10-14 06:30:02