This position involves applying a proven understanding of CMC elements and regulatory requirements to support, and provide guidance to Oncology/ Hematology teams in Japan. This position also supports all CMC regulatory filing activities including the preparation of the Japanese NDA,
Position Purpose: The Regulatory Strategy Group Manager is a key leadership position in Japan Regulatory Affairs (RA) who contributes to achieve organizational vision and goals aligning with the strategic objectives of Global Regulatory Affairs (GRA) and R&D Japan. The Regulatory Strategy Group
Position Purpose: Senior Regularory Strategy Expert is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects in the assigned TAs in Japan. The Senior Regularory Strategy Expert also provides technical guidance
General Information Job Advert Title: Regulatory Lead, CMC RA International Liaison Location: Nihonbashi, Tokyo Division: Regulatory Affairs Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 Reports to the CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Modality Head or Global Head, as a
Position Summary The Associate Director of Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA-CMC) in Japan will be responsible for leading and providing Japan CMC regulatory support for the clinical and commercial product portfolio, which means managing of filing the highly strategic documents
