Associate Director, Regulatory Affairs, Strategic Global Labeling (Neuroscience)

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Influences the department and is recognized as an expert resource on label topics.  Ensures that labeling data is identified, obtained and effectively presented for the registration of products worldwide. Represents the organization at Senior level meetings regarding  Target Product Label (TPL), Development Core Data Sheet (DCDS), Company Core Data Sheets (CCDS),  US Package Insert  (USPI),  European Summary of Product Characteristics (EU SPCs) and other Global Labeling. Under the direction of the Director of Strategic Labeling, establishes labeling policy compliant with changing regulatory environment. Manages labeling staff. Develops and supervises regulatory personnel.

• Develops and directs regulatory label planning for or across assigned product group, area or operational activity and ensures they are in-line with business needs.
• Presents process, strategy and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings.
• Ensures that agreed regulatory labeling strategies or commercial concepts are efficiently implemented, and that strategies are maintained in-line with changing regulatory and business needs.
• Drives strategic labeling processes within teams based on knowledge of success with other products.  Proactively recommends optimal label language based on competitive knowledge and knowledge of project data.
• Works cross functionally with teams such as Research &Dev