Title:  * Executive Regulatory Affairs (Healthcare)

About The Role

• The Executive, Regulatory Affairs is responsible for managing product registration and regulatory compliance activities across the healthcare portfolio in Vietnam. This role ensures that all products are registered, maintained, and commercialized in full alignment with applicable Health Authority requirements and DKSH standards.

What You Will Deliver

• 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, ensuring timely Health Authority approvals
• Coordinate responses to regulatory inquiries and deficiency letters to facilitate smooth product approvals and license maintenance
• Review and approve promotional materials, product advertisements, drug information, and symposium content to ensure regulatory compliance and scientific accuracy
• Provide regulatory guidance to internal teams and clients on local regulatory requirements, promotional activities, and compliance obligations
• Monitor regulatory changes and proactively assess their impact on existing products and business operations, offering actionable recommendations
• Collaborate closely with Supply Chain, Quality Assurance (QA), Medical Affairs, Commercial, and Tender teams to support product importation, distribution, and commercialization
• Prepare regulatory performance reports for senior management and clients, and support inspections, audits, and compliance activities
• Maintain accurate and complete regulatory documentation and records
• Administrative duties and coordination tasks as required

What You Bring

• 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 including Excel, Word, and PowerPoint
• Strong communication, time management, and problem-solving skills with the ability to work effectively in a cross-functional team environment

Why Join DKSH

• At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Regulatory Affairs and Pharmacovigilance.

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