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Regulatory Affairs Team Leader

CÔNG TY TNHH RV GROUP VIỆT NAM · Hồ Chí Minh
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Type
Full-time
Work mode
On-site
Level
Team Leader
Industry
Other
Salary
Thương lượng
Location
Phường Cát Lái, Hồ Chí Minh, Hồ Chí Minh

Overview

  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

Requirements

  • 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.

Benefits

BonusCompany tripsTraining

Summary of facts from the official posting. View original ↗

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