Senior Associate, RA TA Group, Regulatory Affairs (Specialty, Neurology, Eye Care) job opportunity at AbbVie.

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Date2026-03-17T14:15:51.343Z bot
AbbVie Senior Associate, RA TA Group, Regulatory Affairs (Specialty, Neurology, Eye Care)
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RA TA Group, Regulatory Affairs (Specialty, Neurology, Eye Care)

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degreeGeneral
loacation Minato City, Tokyo, Japan
loacation Minato City, T..........Japan
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求人内容Summary of Job Description:  The Regulatory Affairs TA will be responsible for ensuring first time approval of new products and new indications for existing products through participation in local brand teams. Major Responsibilities: Develop local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelinesLead the strategic discussion to accelerate development. Based on the strategy we developed, discuss with the regulatory authorities, and prepare for the early submissionEnsure Japan submission requirements are communicated to relevant regional and global regulatory teamDetermine local Regulatory Risk for submissions and risk mitigation strategies where relevantInform TA team manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applicationsLead major submissions to register NCEs or new indications for existing products when neededLead new product labeling development to achieve the target product profile and post marketing appropriate use of the product.  Maintain and revise current labeling timely and appropriately in accordance with Global Company Core Data Sheet comply with regulatory requirements including GVP.Maintain regulatory records for assigned product portfolio in compliance with local and global proceduresManage interactions with PMDA and MHLW and maintain a productive working relationshipParticipate in / coordinate special project assignments as determined by the Director of Regulatory AffairsSupport to the commercialization of products through participation in local NPI brand teams  

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