Manager, Japan Regulatory Affairs Strategy, Devices & Pharma

Mallinckrodt Pharmaceuticals

Tokyo, Japan
Hybrid
Japan regulatory strategy
Global regulatory dossiers
Health authority liaison
Mallinckrodt Pharmaceuticals is seeking a Manager for Japan Regulatory Affairs Strategy focusing on devices and pharmaceuticals. The role involves leading regulatory strategies, ensuring project completion, and liaising with health authorities in Japan

Job Summary

  • Supports the Global Regulatory Lead in the development and execution of the regulatory strategy for assigned products.
  • Manages the content of global regulatory dossiers and serves as a liaison with the MHLW/PMDA for routine communications.
  • Recommends and implements changes to projects based on expertise, interpretation of regulations, and corporate policies.

Matching Summary

Match Score: 85

Mallinckrodt Pharmaceuticals is seeking a Manager for Japan Regulatory Affairs Strategy focusing on devices and pharmaceuticals. The role involves leading regulatory strategies, ensuring project completion, and liaising with health authorities in Japan.

Skills & Requirements

Must-have

  • Japan regulatory strategy
  • Global regulatory dossiers
  • Health Authority liaison
  • Pharmaceutical and device products
  • Japanese native speaker

Nice-to-have

  • Cross-functional impact negotiation
  • Problem solving and workflow efficiency
  • Online regulatory document submission

Key Requirements

  • Bachelor degree in a scientific field
  • 5 years drug/device development experience
  • 3 years regulatory activities experience
  • Japanese native speaker
  • English proficiency

Work Rights

Not specified

Tailored Resume

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