Regulatory Affairs Team Leader

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 ứng viên

• 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 được hưởng

• 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