Director, RA Global Regulatory Strategy

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 Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates strong understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies with guidance from supervisor.

Responsibilities

• Interfaces with the LRST and AST to implement cross-functional company objectives. Under supervision, leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed product. Proactively seeks expert advice and technical support from cross functional stakeholders, supervisor, and TAH level personnel.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and