Regulatory Affairs Manager

Key Responsibilities

• Ensure of assigned registration submission and approval on time (new registration, renewal registration, variations including new site), in line with local commercial strategies.  
• Ensure regulatory compliance for a sustainable life-cycle management: safety label change, labeling, CMC, PSUR and other MA lifecycle support are performed in accordance with local regulations and relevant Novartis SOPs
• Coordinate with QA/Supply chain departments to support for product’s availability on market.
• Collaborate with commercial team for launching preparation, tender management and promotional material management.
• Ensure of regulatory database updated (DRAGON, REDI, RA Shared documents ...)
• Develop and maintain effective working relationships with Drug Administration of Vietnam and key Stakeholders to support current and future business activities (which are under responsibility of Regulatory Affairs).
• Proactively involve on shaping regulation as assignment by time.
• Ensure compliance to current local regulations: Awareness of current and new local regulations. Interpretation and communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders as per assignment to ensure timely implementation of new regulations and reflect on business strategy.
• Ensure adherence to Global and local processes & Process improvements: Compliance with Global processes and proactively identify areas of improvement with regards to local compliance.  
• Perform other tasks relating to Regulatory activities as assigned.

Minimum Requirements