Manager, Regulatory Affairs, Strategic Global Labeling (Office-based)

Company Description

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.

Job Description

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations.

Responsibilities:

• Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio will include pharma, OTC, and/or device or combination products.
• Lead cross-functional labeling teams to develop comprehensive label strategies and create accurate labeling for development and marketed products by understanding supporting data and leveraging knowledge of labeling regulations, precedent, and company processes to guide strategy and content development.
• Lead cross-functional team discussion of safety-related labeling changes and process the labeling in accordance with internal labeling procedures.
• Maintain documentation within regulatory information management system.
• Co-lead cross-functional labeling and regulatory strategy team (with guidance).
• Provide guidance to affiliates on labeling proposals and responses to health authorities.
• Present/communicate labeling strategies and decisions to senior and executive leadership.
• Represent the department on cross-functional reg