REGULATORY AFFAIRS MANAGER

Job Description : REGULATORY AFFAIRS MANAGER VIETNAM A global healthcare company is seeking a Regulatory Affairs Manager to lead regulatory strategy and product registration activities across pharmaceuticals and medical devices. This role partners with cross-functional teams to ensure compliance, manage product lifecycle activities, and drive timely approvals while supporting business growth in a collaborative and inclusive environment. Develop and execute regulatory strategies for product registrations and lifecycle management. Manage marketing authorisations, variations, import licences, tenders, and promotional approvals. Lead regulatory submissions and maintain relationships with health authorities. Monitor regulatory changes and provide strategic guidance to internal stakeholders. Collaborate with Commercial, Medical, Quality, Supply Chain, and Global teams to ensure compliance and business continuity. Oversee regulatory documentation, safety reporting, and submission tracking. What you bring: Bachelor's degree in Pharmacy (Master's preferred). 10+ years of Regulatory Affairs experience, including years in a managerial role within the pharmaceutical industry. Strong experience with innovative drugs, imported products, and medical device registrations. Hands-on experience managing submissions with DAV and clinical trial applications to ASTT. Strong stakeholder management, regulatory strategy, and communication skills with fluency in English.

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