AI Success™

Job Description

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok

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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 timelines
Lead the strategic discussion to accelerate development. Based on the strategy we developed, discuss with the regulatory authorities, and prepare for the early submission
Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant
Inform TA team manager of Regulatory Affairs and New Product Information (NPI) team of progress of applications and issues impacting local applications
Lead major submissions to register NCEs or new indications for existing products when needed
Lead 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 procedures
Manage interactions with PMDA and MHLW and maintain a productive working relationship
Participate in / coordinate special project assignments as determined by the Director of Regulatory Affairs
Support to the commercialization of products through participation in local NPI brand teams

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About AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

Learn more about us at www.abbvie.com and review our community guidelines at https://www.abbvie.com/social-media-community-guidelines.html.

Industry

Chemicals & Materials

Company Size

10,000+ employees

Headquarters

North Chicago, Illinois

Year Founded

Unknown

Website

abbvie.com

Social Media

Manager, RA TA Group, Regulatory Affairs(Oncology)