Mô tả công việc
1. Dossier Preparation & Submission Execution
Directly supervise the day-to-day preparation, compilation, and submission of registration dossiers (new registrations, renewals, variations) according to the plan set by RA Manager.
Conduct first-level review of dossiers prepared by team members to check completeness, format, and accuracy before escalating for final approval.
Track submission timelines, deadlines, and follow up with team members to avoid delays.
2. Regulatory Follow-up & Authority Correspondence
Monitor the status of submitted dossiers on DAV's system/portal; promptly draft responses to supplementary requests (bổ sung) from authorities.
Maintain the tracking log of all dossiers (status, deadlines, follow-up actions) and escalate risks/delays to RA Manager.
Liaise directly with DAV officers and relevant authorities on operational matters (e.g., document clarification, follow-up on pending queries).
3. Team Supervision & On-the-job Training
Allocate daily/weekly tasks among RA staff and monitor individual workload and progress.
Coach and train new/junior RA staff on dossier formats (CTD), documentation standards, and internal procedures.
Support performance tracking of team members and provide input to RA Manager for evaluations.
4. SOP Implementation & Documentation Control
Implement and maintain internal RA working procedures (SOPs, checklists, templates) to standardize dossier preparation.
Manage the internal filing/archiving system of licenses, certificates, and registration dossiers to ensure easy retrieval and audit-readiness.
5. Cross-Functional Support
Act as the operational contact point with QA/QC, R&D, Sales & Marketing, and Supply Chain on documentation requirements for product launches.
Review labeling, packaging artwork, and advertising materials at working level to check compliance before sending for final sign-off.
6. Reporting
Prepare weekly/monthly status reports on dossier progress and team workload for RA Manager.
Flag regulatory changes or DAV requirement updates noticed during daily work to RA Manager for assessment.
Yêu cầu
Bachelor's Degree in Pharmacy.
Minimum 5 years of experience in Regulatory Affairs, of which at least 1-2 years in a team lead/supervisory (non-managerial) role.
Solid working knowledge of MOH regulations, DAV dossier requirements (CTD format), variation and renewal procedures; experience with imported drug registration is an advantage.
Good English proficiency for technical documentation and email correspondence with foreign partners.
Hands-on experience preparing/reviewing dossiers directly (not only overseeing at a strategic level).
Good coaching/training skills to guide junior staff.
Detail-oriented, well-organized, able to manage multiple deadlines simultaneously.
Proactive, responsible, able to work under pressure.
Quyền lợi
Competitive salary + performance bonus.
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
Bảo hiểm xã hội, Bảo hiểm sức khỏe, Thưởng tháng 13, Team building, Du lịch hàng năm
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)