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

Pfizer Venezuela S.A

Not specified
Post-approval cmc change management
Regulatory strategy development
Internal process development and management
Pfizer Venezuela S.A is seeking a staff member for their Post Approval Change Management group, responsible for regulatory activities related to post-approval CMC (Chemistry, Manufacturing, and Controls) change management for pharmaceutical products. The ideal candidate should possess a science degree, knowledge of local regulatory laws, and strong communication skills, with a preference for those with experience in drug characteristics and interactions with regulatory bodies

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, including changes for drug manufacturers, and develop regulatory strategies for partial change applications.
  • 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 Venezuela S.A is seeking a staff member for their Post Approval Change Management group, responsible for regulatory activities related to post-approval CMC (Chemistry, Manufacturing, and Controls) change management for pharmaceutical products. The ideal candidate should possess a science degree, knowledge of local regulatory laws, and strong communication skills, with a preference for those with experience in drug characteristics and interactions with regulatory bodies.

Skills & Requirements

Must-have

  • Post-approval CMC change management
  • Regulatory strategy development
  • Internal process development and management
  • Pharmaceutical industry trends analysis
  • Cross-functional collaboration

Nice-to-have

  • Strong sense of teamwork
  • Good communication skills
  • Ability to demonstrate leadership
  • Positive attitude

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