Regulatory Affairs Associate

AstraZeneca

Manage regulatory dossiers
Meet bpom requirements
Ensure smooth submission
Manage regulatory dossiers to meet BPOM requirements and ensure smooth submission within globally and locally agreed timelines

Job Summary

  • Manage regulatory dossiers to meet BPOM requirements and ensure smooth submission within globally and locally agreed timelines.
  • Actively participate in cross-functional teams and provide updates on regulatory status to ensure alignment with commercial and company goals.
  • Have a good relationship with Health Authorities (such as BPOM, Kemenkes, or BPJPH).

Matching Summary

Manage regulatory dossiers to meet BPOM requirements and ensure smooth submission within globally and locally agreed timelines.

Skills & Requirements

Must-have

  • Manage regulatory dossiers
  • Meet BPOM requirements
  • Ensure smooth submission
  • Product life cycle management
  • Maintain regulatory databases
  • Manage product artwork

Nice-to-have

  • Patient-focused biopharmaceutical company
  • Science-led organization
  • Empowered to explore
  • Customer-focused mindset
  • Performance-driven

Key Requirements

  • Bachelor's degree in Pharmaceutical Science
  • Minimum of 2 years of experience
  • Working knowledge of BPOM regulations
  • Experience working in cross-functional teams
  • Understanding of drug development process

Work Rights

Not specified

Tailored Resume

Cover Letter