Manager, Technical Regulatory

Roche Holding AG

Shanghai, China
Not specified
Master's degree in life science disciplines
3+ years experience in pharmaceutical or biotech industry
Knowledge of ich, who, and china regulations
Roche Holding AG is seeking a Manager for Technical Regulatory in Shanghai, China, to oversee regulatory activities for a biologics manufacturing pilot project. The role involves strategy recommendations, document authoring, regulatory compliance, and collaboration with key stakeholders, all within a culture that values personal expression and open dialogue

Job Summary

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

Matching Summary

Match Score: 85

Roche Holding AG is seeking a Manager for Technical Regulatory in Shanghai, China, to oversee regulatory activities for a biologics manufacturing pilot project. The role involves strategy recommendations, document authoring, regulatory compliance, and collaboration with key stakeholders, all within a culture that values personal expression and open dialogue.

Skills & Requirements

Must-have

  • Master's Degree in life science disciplines
  • 3+ years experience in pharmaceutical or biotech industry
  • Knowledge of ICH, WHO, and China regulations
  • Experience with CMC regulatory documents
  • Ability to interact with Health Authorities

Nice-to-have

  • Filing experience in Regulatory Affairs
  • Analytical development or supply chain experience
  • MSAT or manufacturing process development experience
  • Knowledge of FDA and EMA regulations
  • Experience with segmented manufacturing regulations

Key Requirements

  • Master's Degree in life science
  • 3 or more years work experience
  • Knowledge of China/EU/USA registration requirements

Work Rights

Not specified

Tailored Resume

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