Regulatory Affairs Manager
DTX Pharma, a Novartis Company
Legal
Vietnam
Band
Level 4
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