Mô tả công việc
1.1. Managing & Coordinating Registration Activities
Build and implement annual registration plans for pharmaceuticals.
Manage, assign tasks, and supervise the preparation and submission of registration dossiers for drugs.
Review, evaluate, and approve dossiers before submitting to the Drug Administration of Vietnam (DAV) and other authorities.
Update and communicate regulatory changes related to pharmaceuticals, variations, renewals, and licensing processes.
1.2. Reviewing & Controlling Drug Dossiers
Assess dossier quality to ensure full compliance with MOH regulations and guidelines for drugs.
Work closely with foreign manufacturers/partners to obtain, standardize, and finalize technical documents (CTD format, GMP, CPP, LOA, etc.).
Coordinate with internal departments (QA, QC, PV, Warehouse, Supply Chain...) to ensure documentation meets regulatory requirements.
Review documents related to product quality, stability data, manufacturing processes, and foreign regulatory certificates.
1.3. Acting as a Regulatory Liaison
Represent the company in working with DAV, local health authorities, and inspection bodies on drug matters.
Track dossier evaluation progress, respond to official letters, and manage additional requests from authorities.
Work with foreign partners to resolve regulatory issues, update technical documentation, and ensure timely approval.
1.4. Personnel Management & Training
Manage and supervise the RA team, including performance evaluation and daily task coordination.
Train staff on regulations for drug registration, documentation standards, and communication with foreign partners.
Develop internal procedures to enhance compliance and dossier preparation efficiency.
1.5. Reporting & Compliance Improvement
Prepare regular reports on registration status for products and present to the Board of Directors.
Propose improvements to optimize the drug registration process and minimize regulatory risks.
Support compliance activities related to drugs, such as post-approval changes and license renewals.
Yêu cầu
Bachelor's Degree in Pharmacy.
Minimum 7 years of experience in Regulatory Affairs, with at least 3 years of managerial experience in pharmaceutical registration in Vietnam preferred.
Strong knowledge of EU-GMP, MOH regulations, DAV guidelines, pharmaceutical variations, and renewal procedures.
Advanced English proficiency, especially strong presentation and communication skills.
Proven experience working directly with foreign manufacturers, principals, or licensors.
Strong leadership, communication, negotiation, and problem-solving skills.
High sense of responsibility, strong attention to detail, and ability to work effectively under pressure.
Quyền lợi
Competitive salary and benefits.
Full insurance package (Social, Health, Unemployment Insurance).
Lunch allowance; company-provided working devices.
Teambuilding activities, annual company trip, birthday gifts, and other company benefits.
Professional environment with opportunities to work directly with international partners.
Clear career path
Thông tin khác
Thời gian làm việc
Thứ 2 - Thứ 6 (từ 08:00 đến 17:00)
Thứ 7 (từ 08:00 đến 12:00)
Giờ làm việc linh hoạt 8h00 - 17h00 / 8h30 - 17h30 / 9h00 - 18h00
Thông tin chung
Nơi làm việc
- - Hồ Chí Minh: 94-96 Nguyễn Văn Kỉnh, Phường Cát Lái (Thành phố Thủ Đức cũ)
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Ứng tuyển bên dưới:
Hạn nộp: 27/07/2026
