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.
About The Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
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