Specialist, RA CMC Small Molecules

Description 【募集の背景 / Purpose & Scope】Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages. Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Utilizes working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application. Expected to support both development and commercial programs/products, end-to-end.【職務の内容 / Essential Job Responsibilities】（雇入れ直後）・Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice from manager on complex issues・Manages technical documents for preparation, review and submission to regulatory agencies. Prepares INDs/CTAs & NDAs/MAAs, amendments & supplements, as well as responses to questions from regulatory agencies. Assesses scientific data again...