Senior Manager- China Regulatory Affairs Cmc & Device

Takeda

Beijing, China
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Cmc regulatory affairs
Product license maintenance
Regulatory compliance strategies
** The Senior Manager of China Regulatory Affairs at Takeda is responsible for ensuring regulatory compliance for new products and amendments while leading a medium-sized team. This role requires advanced knowledge in biotechnology, regulatory practices, and strong leadership skills, all aimed at supporting Takeda's mission of improving global health. **

Job Summary

  • The Senior Manager CMC Regulatory Affairs is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, and for maintaining the currency of product licenses and permits.
  • This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing Better Health to people and a Brighter Future to the world.
  • As a leader of a department, you oversee a medium-sized team of managers, supervisors, or professionals and specialists working on diverse topics.

Matching Summary

Match Score: 75

** The Senior Manager of China Regulatory Affairs at Takeda is responsible for ensuring regulatory compliance for new products and amendments while leading a medium-sized team. This role requires advanced knowledge in biotechnology, regulatory practices, and strong leadership skills, all aimed at supporting Takeda's mission of improving global health. **

Skills & Requirements

Must-have

  • CMC regulatory affairs
  • product license maintenance
  • regulatory compliance strategies
  • prepare regulatory documents
  • stakeholder engagement
  • Good Manufacturing Practices

Nice-to-have

  • advanced change control
  • biotechnology expertise
  • clinical trial management
  • drug development process improvement
  • influencing skills
  • verbal communication skills

Key Requirements

  • Management of medium-sized team
  • Project, budget, schedule management
  • Stakeholder engagement at management levels
  • Presentation of findings at meetings

Work Rights

Not specified

Tailored Resume

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