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Regulatory Affairs Team Leader

CÔNG TY TNHH RV GROUP VIỆT NAM · Hồ Chí Minh
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Trưởng nhóm
Ngành nghề
Ngành nghề khác
Mức lương
Thương lượng
Địa điểm
Phường Cát Lái, Hồ Chí Minh, Hồ Chí Minh

Tổng quan

  • 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.

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

Chế độ thưởngDu lịchĐào tạo

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