Regulatory Affairs Executive - Established Pharmaceuticals Division

Abbott

Hanoi, Vietnam
Not specified; not specified; not specified
Dossier preparation and submission
Vietnam regulatory compliance knowledge
Cmc and cscc system management
The role focuses on executing regulatory activities including dossier preparation and submission for product registration in Vietnam

Job Summary

  • The role focuses on executing regulatory activities including dossier preparation and submission for product registration in Vietnam.
  • Candidates must independently manage technical and legal documents using specific systems like CMC, CSCC, Agile, RINR, and Darius.
  • Abbott offers career development with an international company recognized as a great place to work for diversity and growth.

Matching Summary

The role focuses on executing regulatory activities including dossier preparation and submission for product registration in Vietnam.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Dossier preparation and submission
  • Vietnam regulatory compliance knowledge
  • CMC and CSCC system management
  • External KOL communication skills
  • Product registration lifecycle management

Nice-to-have

  • Strategic product launch support
  • Strong negotiation abilities
  • Cross-functional stakeholder collaboration
  • Problem-solving in regulatory contexts
  • Fluency in Vietnamese and English

Key Requirements

  • Bachelor's Degree in pharmacy or Registered Pharmacist in Vietnam
  • At least 3 years relevant experience in regulatory affairs
  • Knowledge of local regulations and standards

Work Rights

Not specified

Tailored Resume

Cover Letter