Director, RA Global Regulatory Strategy

Role: Global Regulatory Lead (GRL II) for AbbVie's pharmaceutical portfolio, responsible for developing and executing global regulatory strategies to secure and maintain product approvals across therapeutic areas such as immunology, oncology, and neuroscience. Core responsibilities include leading the Global Regulatory Product Team (GRPT), creating strategic dossiers, mitigating regulatory risks, and ensuring compliance throughout product lifecycle stages, including post-approval. The role involves interfacing with cross-functional teams, regulatory agencies, and external stakeholders, and may include leading Labeling Regulatory Strategy Teams (LRST). Requirements include a Bachelor's in life sciences, 7+ years of regulatory experience in pharma, with proven strategic leadership and cross-regional regulatory expertise (US, EU, Japan preferred). Higher education and certifications are advantageous. High-value specifics: experience in global drug development, regulatory strategy development, and extensive knowledge of regulatory policies affecting biologics or small molecules in late-stage development or post-market phases. The position reports to senior management, involves strategic influence, and may include team leadership responsibilities. Work setup details are not specified.