Regulatory Affairs Manager

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

Your Role:

The Regulatory Affairs Manager develops and executes regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. S/he represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and properly maintain regulatory applications to Health Authorities across the Area. This role also interfaces with partner functions (e.g., Commercial, Market Access, Quality Assurance) to ensure Regulatory strategies are aligned with business objectives.

Key responsabilities:

• Provides strategic direction to support the development of compliant and competitive Regulatory programs.
• Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities.
• Effectively incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area.
• Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program.
• Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area.
• Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives.
• Represents Area on process improvement initiatives of low- to medium-complexity; is able to represents the needs of A