Director, Regulatory Affairs Strategy - Cell and Gene Therapy

Responsibilities Steer global regulatory strategy for cell and gene therapies Shape the regulatory path for oncology, immune-mediated, and rare disease programs Lead strategy across key milestones from expedited designations to post-approval maintenance Drive strategy and execution for Health Authority meetings and responses Maintain strong disease area knowledge and lead objective assessments Support delivery of all project-related regulatory milestones Lead preparation of regulatory strategy documents and target product labeling Operate as a core member of Global Product Team and Global Regulatory Strategy Team Foster knowledge sharing across locations and therapy areas Provide mentoring to less experienced colleagues Requirements An advanced degree in a science-related field Five to eight years of experience or appropriate knowledge/experience Understanding of global regulatory science and integration with program strategy Proven experience leading regulatory and cross-functional teams Previous experience in leading Health Authority interactions in major markets Excellent oral, written, and presentation skills Strong organizational skills Ability to work in a fast-paced environment Flexible and proactive with multiple projects #J-18808-Ljbffr Jobtailor