メディカル・バイオ - ＣＭＣ薬事

・Responsible for preparing and/or overseeing the preparation of technically complex regulatory CMC submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
・Oversees preparation and maintenance of country specific labeling and product packaging (region specific).
・Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
・Ensures up-to-date knowledge of regulatory CMC. requirements and communicates relevant changes in regulatory information to project teams and senior management in a timely manner.
・Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or other departments.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

10+ years of experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.
Degree in a scientific field is preferred.

■職種未経験者：不可