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

Pfizer Pfizer · Pharma · Tokyo, Japan

Responsible for regulatory activities related to post-approval CMC (Chemistry, Manufacturing and Controls) change management for pharmaceutical products, contributing to the maintenance of a stable and continuous product supply. This includes managing product approval changes, changes for drug manufacturers, developing regulatory strategies, providing regulatory information, and developing/managing internal processes.

What you'd actually do

  1. Manage product approval changes in order to keep stable product supply.
  2. Manage the changes for manufacturer of drugs and develop regulatory strategies for application for partial change.
  3. Provide regulatory information to Development Japan (DJ) by collecting, analyzing, and leveraging pharmaceutical industry trends and practices to support development and regulatory strategy development.
  4. Develop and manage internal processes, including processes that involve cross-functional collaboration.

Skills

Required

  • Graduated science college/university
  • Knowledge and understanding of local regulatory law and practical skills
  • A positive candidate with a strong sense of teamwork, good communication skills, and the ability to demonstrate leadership.
  • Basic knowledge of society in general as well as science and technology
  • English speaking/hearing and writing skill to work smoothly with global colleagues
  • Basic IT skills

Nice to have

  • Basic knowledge of Drug Characteristics and Drug manufacturing
  • Experiences outside activities (JPMA, DIA etc.)
  • Experience PMDA interaction related to CMC

What the JD emphasized

  • Knowledge and understanding of local regulatory law and practical skills
  • English speaking/hearing and writing skill to work smoothly with global colleagues
  • Basic knowledge of Drug Characteristics and Drug manufacturing
  • Experience PMDA interaction related to CMC