【R&D】薬事申請グループ スタッフ / Post Approval Change Management
Job Description
1. Job Objective:
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.
2. Job Roles and Responsibilities:
Post approval CMC change management
Manage product approval changes in order to keep stable product supply.
Manage the changes for manufacturer of drugs and develop regulatory strategies for application for partial change.
Regulatory Information
Provide regulatory information to Development Japan (DJ) by collecting, analyzing, and leveraging pharmaceutical industry trends and practices to support development and regulatory strategy development.
Develop and manage internal process
Develop and manage internal processes, including processes that involve cross-...