Director, Regulatory Affairs Strategy – Cell and Gene Therapy

Role Overview

• 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

Benefits

• Health benefits including medical, prescription drug, dental, and vision coverage
• Paid vacation and holidays
• Paid leaves
• Qualified retirement program [401(k) plan]
• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program