Senior Manager Regulatory Affairs

This role is also responsible for leading the preparation and submission of product Technical Files, Standard Technical Documentation, and other related documents for market authorizations in Japan. The Director will drive the development and implementation of regulatory strategies for assigned projects, covering new product introductions, product modifications, and manufacturing improvements in Japan. Additionally, the role involves creating and enforcing local regulatory procedures and educating others on Japanese regulatory standards. The Director will collaborate with the Japanese leadership team and other international functions to ensure product registration and compliance in Japan.