Job Description Summary Ensure of regulatory compliance and achieving registration licenses on time from local authority, in line with company’s objectives. Location: Ha Noi Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Job Description 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
• University graduate, preferably with a degree in Pharmacy or Medicine
• Fluent in English and Vietnamese, enabling effective local and global collaboration
• 5+ years of experience in Drug Regulatory Affairs or Drug Registration Management
• Strong critical and strategic thinking, with proven communication, influencing, and negotiation capabilities
• Demonstrated independent and innovative mindset, solid understanding of product‑relevant bioscience, and ability to build trust‑based relationships with key regulatory authorities
Skills Desired Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance