【r&d】薬事申請グループ スタッフ / Post Approval Change Management

Pfizer

Hybrid
Science college or university degree
Knowledge of local regulatory law
English speaking and writing skills
Pfizer is seeking a staff member for their R&D Post Approval Change Management team, focusing on regulatory activities related to post-approval Chemistry, Manufacturing, and Controls (CMC) change management. The ideal candidate will possess a scientific background, strong communication skills, and be able to collaborate effectively in a team setting

Job Summary

  • The role is responsible for managing post-approval CMC change management to ensure stable and continuous product supply.
  • Candidates must develop regulatory strategies for partial change applications and manage interactions regarding drug manufacturer changes.
  • The position requires collecting and analyzing pharmaceutical industry trends to support development and regulatory strategy for Development Japan.

Matching Summary

Match Score: 85

Pfizer is seeking a staff member for their R&D Post Approval Change Management team, focusing on regulatory activities related to post-approval Chemistry, Manufacturing, and Controls (CMC) change management. The ideal candidate will possess a scientific background, strong communication skills, and be able to collaborate effectively in a team setting.

Skills & Requirements

Must-have

  • Science college or university degree
  • Knowledge of local regulatory law
  • English speaking and writing skills

Nice-to-have

  • Experience with JPMA or DIA activities
  • PMDA interaction experience related to CMC
  • Strong teamwork and leadership abilities

Key Requirements

  • Graduated science college/university
  • Understanding of PMDA regulations
  • Basic IT skills

Work Rights

Not specified

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