Assistant Manager, Regulatory Affairs

• Bachelor's degree in Pharmacy or a related discipline.
• More than 5 years of experience in Regulatory Affairs, with a demonstrated track record in product registration and lifecycle management.
• Strong command of local Vietnamese regulatory requirements and Health Authority frameworks applicable to healthcare products.
• Proficiency in English, both written and spoken, enabling effective communication with regulators, clients, and cross-functional teams.
• Competence in Microsoft Office applications to support documentation, reporting, and regulatory submissions.
• Effective communicator and collaborative team member with strong time management and problem-solving capabilities.

• 100%  offered salary and mandatory socical insurance in 2 months probation
• Premium healthcare insurance 
• Engage in diverse training programs which surely help strengthen both your personal and professonalism.

1. 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.

2. Handle promotional materials: product advertisement, symposium

3. 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.
• Support business development initiatives by providing regulatory feasibility assessments and strategic input.

3. Cross-functional collaboration

• Work closely with Supply Chain, Quality Assurance, Pharmacovigilance, Medical Affairs, Commercial, and other departments to ensure smooth product importation, distribution, and commercialization.
• Provide regulatory support for product launches and business initiatives.

4. 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.

5. Other responsibilities

• Support strategic projects assigned by senior management.
• Perform other duties as required by the Head of Regulatory Affairs.