Regulatory Affairs Associate

Astrazeneca

Manage regulatory dossiers
Meet bpom requirements
Achieve committed approval timelines
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.
  • Here you’ll have the opportunity to make a meaningful difference to patients’ lives.

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
  • Achieve committed approval timelines
  • Participate in cross-functional teams
  • Maintain regulatory databases
  • Manage product artwork
  • Oversee product life cycle management

Nice-to-have

  • Science-led patient-focused biopharmaceutical company
  • Empowered to explore
  • Pioneering the next wave of science
  • Shaping the patient ecosystem
  • Embraces diversity and equality of opportunity

Key Requirements

  • Bachelor's degree in Pharmaceutical Science
  • Minimum of 2 years of experience
  • Demonstrated working knowledge of BPOM regulations
  • Experience working in cross-functional teams
  • Understanding of the drug development process
  • Strong written and verbal communication skills
  • Ability to collaborate and work effectively

Work Rights

Not specified

Tailored Resume

Cover Letter