Senior Manager/associate Director, Regulatory Affairs - Hematology & Oncology Early Development Ta

Johnson & Johnson

Beijing, China
Master's degree in life sciences
5+ years regulatory affairs experience
China regulatory system expertise
This role is responsible for end-to-end regulatory strategy and execution for new asset development in Hematology/Oncology early development within China

Job Summary

  • This role is responsible for end-to-end regulatory strategy and execution for new asset development in Hematology/Oncology early development within China.
  • The incumbent will serve as the primary liaison with China regulatory agencies, leading interactions including briefing books and face-to-face meetings.
  • Candidates must possess a Master's degree or above in chemistry, pharmaceutics, biology, or a related life-science discipline with over 5 years of experience.

Matching Summary

This role is responsible for end-to-end regulatory strategy and execution for new asset development in Hematology/Oncology early development within China.

Skills & Requirements

Must-have

  • Master's degree in life sciences
  • 5+ years regulatory affairs experience
  • China regulatory system expertise
  • Hematology and Oncology development
  • CTA, NDA, BLA submission preparation

Nice-to-have

  • Growth mindset in matrix organization
  • Strong storytelling and presentation skills
  • Experience with lifecycle management
  • Cross-functional collaboration abilities
  • Strategic thinking and risk mitigation

Key Requirements

  • Master's degree in life science
  • 5+ years MNC pharmaceutical RA experience
  • Proficiency in English communication
  • Knowledge of China drug registration regulations

Work Rights

Not specified

Tailored Resume

Cover Letter