Senior Director, Regulatory Affairs Strategy – Cell and Gene Therapy

Responsibilities

• Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program
• Serve as global regulatory lead for complex, multi-indication programs
• Lead strategy for agency meetings, information requests and expedited pathway designations
• Direct the planning and construction of the global dossier and core prescribing information
• Represent Regulatory Affairs on Global Product Teams
• Continuously assess emerging data against program aspirations
• Oversee all regulatory deliverables and milestones
• Lead a Global Regulatory Strategy Team for specific indications/programs
• Build strong relationships with regulatory stakeholders
• Lead and promote the development of novel regulatory tools and technology
• Maintain accountability for product maintenance and compliance activities associated with marketed brands

• An advanced degree in a science related field and seven to ten years of experience and/or appropriate knowledge/experience
• Demonstrated success in cell and/or gene therapy regulatory strategy
• Deep understanding of global regulatory science and integration with program strategy
• Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs
• Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
• Proven experience leading regulatory and cross-functional teams, and stakeholder management
• Ability to think strategically and critically and evaluate risks to regulatory activities
• 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 in a hands‑on fashion
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
• Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations