Sr. Specialist/associate Manager, Regulatory Affairs - Cell Therapy

AstraZeneca

Beijing, China
Maintain regulatory compliance
Develop regulatory strategies
Monitor regulatory environment
Develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch for the allocated portfolio

Job Summary

  • Develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch for the allocated portfolio.
  • Maintain product licenses in assigned portfolio through timely renewal to a high standard and project manage changes in product licenses.
  • Actively develop excellent relationships with local regulatory authorities and external stakeholders to build up AZ’s good image.

Matching Summary

Develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch for the allocated portfolio.

Skills & Requirements

Must-have

  • Maintain regulatory compliance
  • Develop regulatory strategies
  • Monitor regulatory environment
  • Drive issue management
  • Build relationships with regulatory authorities

Nice-to-have

  • High degree of honesty
  • Task oriented with a "Big Picture" approach
  • Embraces diversity and equality
  • Harnessing industry-leading skills

Key Requirements

  • Bachelor or above in Pharmacy, Medical, Biology
  • Fully understand China regulatory practices
  • Strong ability on team management
  • > 2 years experience in drug/biologic manufacturing is a plus
  • Fluent in English reading/writing/listening/speaking

Work Rights

Not specified

Tailored Resume

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