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

Pfizer

Tokyo, Japan
**
Science college or university degree
Understanding of local regulatory law
English speaking and writing skills
** Pfizer is seeking a staff member for its Post Approval Change Management group in Tokyo, Japan, focusing on regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical products. The ideal candidate will have a science background, understanding of regulatory laws, and strong teamwork and communication skills. **

Job Summary

  • The role is responsible for regulatory activities related to post-approval CMC change management to ensure stable product supply.
  • Candidates must manage changes for drug manufacturers and develop regulatory strategies for partial change applications.
  • The position involves collecting and analyzing pharmaceutical industry trends to support development and regulatory strategy.

Matching Summary

Match Score: 75

** Pfizer is seeking a staff member for its Post Approval Change Management group in Tokyo, Japan, focusing on regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical products. The ideal candidate will have a science background, understanding of regulatory laws, and strong teamwork and communication skills. **

Skills & Requirements

Must-have

  • Science college or university degree
  • Understanding of local regulatory law
  • English speaking and writing skills
  • Cross-functional collaboration experience

Nice-to-have

  • Positive candidate with strong teamwork
  • Experience in industry associations like JPMA
  • Ability to demonstrate leadership skills

Key Requirements

  • Graduated science college/university
  • Knowledge of PMDA interaction related to CMC
  • Basic knowledge of Drug Characteristics and manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter