About the Role
As an Assistant Manager, Regulatory Affairs, you are a key enabler of DKSH's healthcare business in Vietnam, ensuring that products reach the market compliantly and on time. Your regulatory expertise directly supports client success, business growth, and DKSH's reputation as a trusted market expansion partner.
What You Will Deliver
- Drive timely product approvals by leading the preparation, review, submission, and maintenance of registration dossiers in full compliance with Vietnamese Health Authority regulations.
- Shape regulatory strategy by developing and executing plans for new product registrations, renewals, variations, and post-approval changes aligned with business objectives.
- Safeguard commercialization timelines by proactively monitoring registration schedules and coordinating responses to regulatory inquiries and deficiency letters.
- Protect the integrity of DKSH's product portfolio by ensuring the continuous compliance and maintenance of all product licenses and registrations.
- Support compliant market promotion by managing the review and submission of promotional materials, including product advertisements and symposium content.
- Serve as a trusted regulatory advisor to clients and internal departments on local regulatory requirements, compliance obligations, and emerging regulatory developments.
- Anticipate and mitigate regulatory risk by monitoring changes in regulations and guidelines, assessing their impact on existing products, and delivering proactive recommendations.
- Enable business growth by providing regulatory feasibility assessments and strategic input for
business development initiatives.
- Facilitate smooth product launches and importation by collaborating closely with Supply Chain, Quality Assurance (QA), Pharmacovigilance, Medical Affairs, Commercial, and other functions.
- Strengthen organizational accountability by preparing performance reports for senior management and clients, and supporting inspections, audits, and regulatory compliance reviews.
- Maintain regulatory integrity through accurate, complete, and audit-ready documentation and record management.
Administrative duties and coordination tasks as required.
- 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.
