Technical Regulatory

Roche Holding AG

Shanghai, China
**
Master's degree in life science disciplines
3+ years experience in pharmaceutical or biotech industry
Knowledge of china regulatory guidelines and ich standards
** Roche Holding AG is seeking a Technical Regulatory professional to manage end-to-end regulatory activities for a biologics segmented manufacturing pilot project in Shanghai, China. The ideal candidate will have experience in regulatory affairs and a strong understanding of both local and international regulations to ensure compliance and facilitate timely approvals. **

Job Summary

  • The role involves performing end-to-end regulatory activities for biologics segmented manufacturing pilot projects in China to ensure timely approvals.
  • Candidates will support policy influencing and interact directly with Health Authorities on defined matters regarding segmented manufacturing.
  • Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

Match Score: 75

** Roche Holding AG is seeking a Technical Regulatory professional to manage end-to-end regulatory activities for a biologics segmented manufacturing pilot project in Shanghai, China. The ideal candidate will have experience in regulatory affairs and a strong understanding of both local and international regulations to ensure compliance and facilitate timely approvals. **

Skills & Requirements

Must-have

  • Master's Degree in life science disciplines
  • 3+ years experience in pharmaceutical or biotech industry
  • Knowledge of China regulatory guidelines and ICH standards

Nice-to-have

  • Experience with FDA and EMA regulations
  • Filing experience in Regulatory Affairs
  • Analytical development or supply chain background

Key Requirements

  • Master's Degree in life science
  • 3 or more years work experience
  • Experience generating technical registration dossier for China/EU/USA

Work Rights

Not specified

Tailored Resume

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