Mô tả công việc
Prepare, compile, and submit registration dossiers for imported pharmaceutical products in compliance with Vietnam regulatory requirements (DAV - Drug Administration of Vietnam).
Proactively track submission progress, ensure timely responses to regulatory queries, and facilitate the successful obtainment of marketing authorizations.
Coordinate with overseas manufacturers and partners to collect required documentation (e.g., CTD dossiers, GMP certificates, CPP, etc.).
Review technical documents to ensure completeness, accuracy, and compliance with current regulations and guidelines.
Monitor regulatory changes and provide updates to internal stakeholders.
Maintain and update registration database and product lifecycle management (variations, renewals, amendments).
Support internal audits and inspections related to regulatory compliance.
Yêu cầu
Bachelor's degree in Pharmacy (mandatory).
Minimum 3-5 years of experience in pharmaceutical regulatory affairs, with a strong focus on registration of imported/foreign products.
Solid understanding of Vietnamese pharmaceutical regulations and registration procedures.
Experience working with CTD/ACTD dossiers is required.
Good communication skills and ability to work with international partners.
Proficient in English (both written and spoken), especially in technical documentation.
Strong attention to detail, organizational skills, and ability to meet deadlines.
Ability to work independently as well as collaboratively in a team environment.
Preferred Qualifications
Experience handling dossiers for EU/US or other regulated markets is an advantage.
Familiarity with eCTD systems and regulatory submission tools.
Prior experience interacting directly with DAV is highly desirable.
Quyền lợi
Competitive salary and performance-based bonus.
Professional and dynamic working environment.
Opportunities for training and career advancement.
Health insurance and other company benefits in accordance with labor law.
Bảo hiểm xã hội, Bảo hiểm full lương, Khám sức khỏe định kỳ, Team building, Du lịch hàng năm, Thưởng tháng 13, Thưởng hiệu quả làm việc
Thông tin khác
Thời gian làm việc
Thứ 2 - Thứ 6 (từ 08:30 đến 18:00)
Thông tin chung
Nơi làm việc
- - Hồ Chí Minh: Văn phòng B602, Tòa tháp B, Tầng 6, Tòa nhà Millennium, số 132 Bến Vân Đồn (Quận 4 cũ), Phường Khánh Hội (Quận 4 cũ)
- - Hà Nội: 29 Huỳnh Thúc Kháng Hạ, Quận Đống Đa cũ), Phường Láng (quận Đống Đa cũ)