Manager, RA Product Management APAC

Description 【募集の背景 / Purpose & Scope】This position leads development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the APAC-GCN region, in alignment with Therapeutic Areas for maintenance activities.Provides proactive guidance to internal groups and affiliates or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.Creates Content Planner and submission timelines for maintenance activities in collaboration with Therapeutic Areas, CMC-RA, Labelling and Affiliates / Business Partners, and/or other relevant functions as applicable.Coordinates and monitor timelines for the execution of the Content Planner.Contribute submission strategy setting for MAAs and post-approval variations with robust knowledge on relevant regulationsSupport to create and complete local regulatory documents for various submissions including, but not limited to, MAAs and the...