Regulatory Affairs Manager

Novartis

Ha Noi, Vietnam
5+ years drug regulatory affairs experience
Fluent in english and vietnamese
University degree in pharmacy or medicine
The role ensures regulatory compliance and achieves timely registration licenses from local authorities in Vietnam

Job Summary

  • The role ensures regulatory compliance and achieves timely registration licenses from local authorities in Vietnam.
  • Candidates must coordinate with commercial, QA, and supply chain departments to support product availability and market launches.
  • The position requires maintaining effective relationships with the Drug Administration of Vietnam and interpreting new local regulations for business strategy.

Matching Summary

The role ensures regulatory compliance and achieves timely registration licenses from local authorities in Vietnam.

Skills & Requirements

Must-have

  • 5+ years Drug Regulatory Affairs experience
  • Fluent in English and Vietnamese
  • University degree in Pharmacy or Medicine
  • Knowledge of local Vietnamese regulations
  • Experience with registration submissions

Nice-to-have

  • Strategic thinking and negotiation skills
  • Ability to shape regulation proactively
  • Strong critical and innovative mindset
  • Experience with DRAGON and REDI databases
  • Collaboration with QA and Supply Chain teams

Key Requirements

  • 5+ years experience in Drug Regulatory Affairs
  • Degree in Pharmacy or Medicine
  • Fluency in English and Vietnamese

Work Rights

Must be accessible to Ha Noi location; relocation not supported

Tailored Resume

Cover Letter