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

 

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance