Regulatory Affairs Manager

**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 (Inactive), Regulatory Compliance