Regulatory Affairs Executive (Pharma, Hanoi)

About the role

A listed multinational pharmaceutical group with a portfolio spanning specialty generics, oncology and branded medicines is looking for a Regulatory Affairs Executive in Hanoi. Vietnam is a priority growth market for the group, which is building a commercial team covering hospital and pharmacy channels; new joiners will have room to shape how the business grows locally.

Key responsibilities

• Manage regulatory activities for assigned products throughout their lifecycle, from new registration submissions to post-approval activities such as variations, renewals, safety updates, artwork changes and other post-approval tasks.
• Plan, prepare, compile, submit and follow up regulatory dossiers to ensure timely submissions and approvals.
• Work closely with the global regulatory team and Head Office on dossier preparation, regulatory requirements and registration strategies.
• Monitor registration progress with the Drug Administration of Vietnam (DAV) and follow up on dossier status, seeking clarification and guidance when needed.
• Keep up to date with Vietnamese pharmaceutical regulations and advise the global team and internal stakeholders on requirements, guidelines, procedures and regulatory risks.
• Maintain regulatory databases, tracking tools and document management systems.
• Support Commercial, Supply Chain and Quality by advising on regulatory pathways and requirements.
• Review and approve product artworks, labeling, packaging and promotional materials for compliance with Vietnamese regulations.
• Carry out other regulatory duties and special projects as assigned by the manager.

Required profile

• Bachelor's degree in Pharmacy or a related field.
• At least 4 years of relevant experience in the pharmaceutical industry.
• Proficiency in written and spoken English.
• No disqualification from pharmaceutical practice or operations.

Required skills

• Good computer literacy, including MS Office and relevant systems.
• Analytical thinking, problem-solving, planning and organizational skills.
• Knowledge of regulatory strategy and compliance, project management capabilities.
• Strong influencing and persuasion skills.