Director, RA Global Regulatory Strategy

Role: Global Regulatory Strategy Director responsible for developing and executing international regulatory plans to secure and sustain market approvals across therapeutic areas such as immunology, oncology, and neuroscience. Objectives include leading global regulatory teams, ensuring compliance, and providing strategic guidance throughout product lifecycle management. Responsibilities encompass leading cross-functional teams, creating global regulatory strategies, managing risk assessments, and influencing regulatory policies. The role involves serving as primary interface with regulatory authorities, preparing regulatory dossiers, and aligning strategies with corporate and global standards. Required qualifications include a bachelor's degree in life sciences, 7+ years of regulatory experience (with at least 5 in a strategic leadership role), drug development experience in the US and CMC, and proven ability to develop global regulatory strategies. Preferred qualifications include 10+ years in pharma regulatory activities, experience in multiple major regions (US, EU, Japan), and advanced degrees or certifications. High-value specifics include involvement in biologics or small molecules, post-approval lifecycle management, and cross-regional regulatory influence. The position reports to senior management and involves strategic decision-making and stakeholder influence. Location and travel specifics are not provided.