Pharmaceutical Affairs Manager, Vietnam

Position description
Liaise and manage the regulatory, pharmacovigilance ("PV") and medical governance ("MG") matters in Vietnam.
Accountabilities and Activities
• Compilation and submission of new product registrations, license renewals, variations, site registrations, life cycle management activities.
• Maintain good record, databases, filing system of product registration and licenses and reviewing new business development dossiers for Vietnam.
• Responsible for developing and enhancing relationships with key external agencies (regulatory agencies and if applicable, service providers). Manage the interface with government departments throughout the lifecycle of a product and develop a long-term and positive relationship characterized by Integrity and Compliance.
• Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner to achieve business objectives.
• Liaise with distributor to manage product quality complaint.
• Develop effective PV strategies, systems, and procedures to align with business strategies, organizational policies, and local regulations.
• Responsible for managing MG functions throughout product lifecycle to align with the organization's strategy, operations, regulatory, legal, and risk requirements.
• Provide recommendations and decisions on PV and MG issues including proactive risk management and mitigation.
• Responsible for new employee training and annual/periodic training of Enquiry Handling Training and related procedural training.
• Handle ad-hoc request/project requested by supervisor.
• Work in unison with Aspen's local, Asia regional, Global and Group functions to deliver the desired outcome
Position Objectives and/or Key Result Areas
• Ensure compliance with, and maintenance of, the existing licenses for Aspen's portfolio, effective and timely approval of all marketing authorizations
• Define Regulatory priorities in line with the business objectives