Executive Regulatory Affairs (Healthcare)

About the role

DKSH Vietnam is looking for an Executive Regulatory Affairs professional to lead the registration and lifecycle management of healthcare products. The role involves shaping regulatory strategies, ensuring compliance, and supporting market access for a diverse portfolio.

Key responsibilities

• Lead the preparation, review, submission, and maintenance of product registration dossiers in line with Vietnamese regulations.
• Develop and execute regulatory strategies for new product registrations, renewals, variations, and post‑approval changes.
• Monitor registration timelines and coordinate with Health Authorities to secure timely approvals.
• Respond to regulatory inquiries and deficiency letters, providing clear and compliant documentation.
• Collaborate with cross‑functional teams to align regulatory activities with product development and commercial plans.

Required profile

• Degree in Pharmacy or a related discipline.
• Minimum 5 years of experience in Regulatory Affairs within the healthcare or pharmaceutical industry.
• Strong knowledge of local regulatory requirements and Health Authority processes in Vietnam.
• Fluent in English, both written and spoken.
• Proficient in Microsoft Office applications (Excel, Word, PowerPoint).

Required skills

• Regulatory Affairs
• Drug Registration
• Clinical Pharmacy
• Pharmaceuticals
• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint