【r&d】薬事申請グループ スタッフ / Post Approval Change Management
Pfizer
Post-approval cmc change management
Regulatory strategies for application
Collecting and analyzing industry trends
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
Job Summary
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.
Manage product approval changes in order to keep stable product supply.
Provide regulatory information to Development Japan (DJ) by collecting, analyzing, and leveraging pharmaceutical industry trends and practices to support development and regulatory strategy development.
Matching Summary
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.
Skills & Requirements
Must-have
post-approval CMC change management
regulatory strategies for application
collecting and analyzing industry trends
develop and manage internal processes
English speaking/hearing and writing skill
Nice-to-have
strong sense of teamwork
good communication skills
ability to demonstrate leadership
basic knowledge of society
basic IT skills
Key Requirements
Graduated science college/university
Knowledge and understanding of local regulatory law
Basic knowledge of Drug Characteristics and Drug manufacturing