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← DKSH Vietnam Co., Ltd.

Executive Regulatory Affairs (Healthcare)

DKSH Vietnam Co., Ltd. · Hồ Chí Minh
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Type
Full-time
Work mode
On-site
Level
Staff
Industry
Other
Salary
Thương lượng
Location
Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh

Overview

  • Regulatory registration and product lifecycle management
  • Lead the preparation, review, submission, and maintenance of product registration dossiers in compliance with applicable regulations.
  • Develop and execute regulatory strategies for new product registrations, renewals, variations, and post-approval changes.
  • Monitor registration timelines and ensure timely approvals from Health Authorities.
  • Coordinate responses to regulatory inquiries and deficiency letters to facilitate product approvals.
  • Ensure continuous compliance and maintenance of all product licenses and registrations.
  • Handle promotional materials:
  • Review and approve promotional materials, product advertisements, drug information, and symposium content to ensure compliance with applicable regulations and company policies.
  • Provide regulatory guidance to relevant teams on promotional activities.
  • Ensure promotional claims are accurate, scientifically supported, and aligned with approved product information.
  • Regulatory consulting
  • Provide regulatory advice and guidance to clients and internal departments regarding local regulatory requirements and compliance obligations.
  • Monitor changes in regulations, guidelines, and industry requirements.
  • Assess regulatory impacts on existing products and business operations and provide proactive recommendations.
  • Cross-functional collaboration
  • Work closely with Supply Chain, Quality Assurance, Medical Affairs, Commercial, Tender and other departments to ensure smooth product importation, distribution, and commercialization.
  • Compliance and reporting
  • Ensure regulatory compliance across all products and activities.
  • Prepare the performance reports to senior management/ clients
  • Support inspections, audits, and regulatory compliance activities.
  • Maintain accurate and complete regulatory documentation and records.
  • Support other tasks assigned by RA management

Summary of facts from the official posting. View original ↗

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