Regulatory Affairs Team Leader - Trưởng Nhóm Đăng Ký Thuốc

POSITION OVERVIEW | TỔNG QUAN VỊ TRÍ
We are seeking an experienced Regulatory Affairs Team Leader to lead the Regulatory Affairs team for imported pharmaceutical products in Vietnam. This role is responsible for managing daily regulatory operations, leading the team, ensuring compliance with Ministry of Health (MOH) regulations, and supporting the company's portfolio expansion and business growth.
KEY RESPONSIBILITIES | NHIỆM VỤ CHÍNH
Leadership & Team Management
• Lead, supervise, coach, and develop the Regulatory Affairs team.
• Allocate workload, monitor project progress, and ensure timely completion of regulatory activities.
• Review and approve regulatory dossiers before submission.
• Build a collaborative, accountable, and high-performing team.
Regulatory Affairs Operations
• Oversee preparation, review, and submission of CTD dossiers for imported pharmaceutical products.
• Manage product registrations, renewals, variations, post-approval changes, and deficiency responses.
• Ensure compliance with DAV, MOH regulations, GMP requirements, and applicable pharmaceutical legislation.
• Monitor regulatory changes and implement updates within the organization.
Cross-functional Collaboration
• Coordinate with overseas manufacturers and regulatory authorities.
• Collaborate closely with QA, Import & Export, Supply Chain, Sales, Marketing, and other departments to support product registration and launches.
• Resolve regulatory issues and provide regulatory guidance to internal stakeholders.
Process Improvement
• Improve Regulatory Affairs procedures and enhance operational efficiency.
• Perform other duties assigned by Management.