Senior Manager CMC Dossier Strategy and Leadership

Job description

Company Description About AbbVie: 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Purpose: This position ensures that global regulatory CMC dossiers for clinical and marketing applications are created and aligned with current AbbVie’s CMC best practices. The role works with CMC teams during development of various projects and influences generation of adequate data packages suitable for regulatory submissions. The role collaborates to and authors CTDs to communicate a single, integrated strategy to health authorities, facilitates timely creation of regulatory CMC query responses and CMC briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content. Responsibilities: •Embedded in the C...