(senior) Specialist, Regulatory Affairs - Rare Disease

AstraZeneca

Implement regulatory strategies
Maintain product licenses
Manage regulatory support systems
Implement regulatory strategies to achieve in-time and high quality approval and facilitate full speed launch

Job Summary

  • Implement regulatory strategies to achieve in-time and high quality approval and facilitate full speed launch.
  • Maintain product licenses through timely lifecycle management with high standard.
  • AstraZeneca embraces diversity and equality of opportunity.

Matching Summary

Implement regulatory strategies to achieve in-time and high quality approval and facilitate full speed launch.

Skills & Requirements

Must-have

  • implement regulatory strategies
  • maintain product licenses
  • manage regulatory support systems
  • monitor local regulatory environments
  • adherence to AZ code of conduct

Nice-to-have

  • establish relationships with authorities
  • exert regulatory influence
  • good coordination for stakeholders
  • strong collaboration across teams

Key Requirements

  • Minimum 4 years MNC Pharma regulatory affairs experience
  • Minimum 2 years experience in below position
  • Bachelor degree or above in Pharmacy, Medical, Biology
  • Understand China regulatory practices
  • Fluent in oral and written English

Work Rights

Not specified

Tailored Resume

Cover Letter