Associate Director, Regulatory Affairs - Cell Therapy

AstraZeneca

Beijing, China
China regulatory practices and regulation
Networking with regulatory authorities
Stakeholder management
Responsible for managing multiple brands/compounds to obtain regulatory approval for various development, manufacturing, sales, and marketing activities

Job Summary

  • Responsible for managing multiple brands/compounds to obtain regulatory approval for various development, manufacturing, sales, and marketing activities.
  • Assist RA TA head to set strategic regulatory direction for China portfolio to achieve in-time and high-quality approval and facilitate full speed launch.
  • Supervise, coach, and support junior staff, encouraging best practice sharing and taking accountability for actions.

Matching Summary

Responsible for managing multiple brands/compounds to obtain regulatory approval for various development, manufacturing, sales, and marketing activities.

Skills & Requirements

Must-have

  • China regulatory practices and regulation
  • Networking with regulatory authorities
  • Stakeholder management
  • Complex regulatory environment assessment
  • Crisis management

Nice-to-have

  • Building trustful relationships
  • Collaboration across teams
  • Challenging status quo
  • Open and trusting atmosphere

Key Requirements

  • Minimum 12 years working experience in regulatory affairs of MNC
  • Minimum 2 years experience in specific positions
  • Bachelor degree or above in Pharmacy, Medical, Biology or related field
  • Fluent in both oral and written English

Work Rights

Not specified

Tailored Resume

Cover Letter