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

pfizer.ch

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Post-approval cmc change management
Regulatory strategy development
Collecting and analyzing industry trends
** Pfizer is seeking an R&D staff member for their Post Approval Change Management team, responsible for managing regulatory activities related to post-approval Chemistry, Manufacturing and Controls (CMC) changes. The ideal candidate will have a science background, a solid understanding of regulatory requirements, and strong teamwork and communication skills. **

Job Summary

  • Responsible for regulatory activities related to post-approval CMC change management for pharmaceutical products, contributing to the maintenance of a stable and continuous product supply.
  • Manage product approval changes and changes for manufacturers of drugs, developing regulatory strategies for application for partial change.
  • Provide regulatory information to Development Japan by collecting, analyzing, and leveraging pharmaceutical industry trends and practices to support development and regulatory strategy development.

Matching Summary

Match Score: 75

** Pfizer is seeking an R&D staff member for their Post Approval Change Management team, responsible for managing regulatory activities related to post-approval Chemistry, Manufacturing and Controls (CMC) changes. The ideal candidate will have a science background, a solid understanding of regulatory requirements, and strong teamwork and communication skills. **

Skills & Requirements

Must-have

  • post-approval CMC change management
  • regulatory strategy development
  • collecting and analyzing industry trends
  • internal process development and management
  • cross-functional collaboration

Nice-to-have

  • strong sense of teamwork
  • good communication skills
  • demonstrate leadership
  • positive candidate

Key Requirements

  • Graduated science college/university
  • Knowledge of local regulatory law
  • English speaking/hearing and writing skill
  • Basic IT skills

Work Rights

Not specified

Tailored Resume

Cover Letter