Sr. / Director Global Regulatory Affairs - Gene Therapy

A global biopharmaceutical organization focused on serious and rare diseases is seeking a Global Regulatory Lead (GRL) to lead global programs across their gene therapy pipeline. The company values meaningful work, collaboration, and a culture where curiosity and impact are central.Role OverviewThe GRL develops and drives global regulatory strategies, guides cross-functional teams through development and submission activities, and leads interactions with U.S. and global Health Authorities. The role oversees regulatory submissions, agency communications, and risk-mitigation planning across assigned programs.Key Responsibilities• Lead global regulatory strategy across clinical, preclinical, and lifecycle activities• Identify regulatory risks and define mitigation approaches• Advise on IND and CTA strategies and support cross-functional teams• Direct planning and preparation of global submissions and briefing packages• Oversee materials for regulatory meetings and deliver clear, high-quality presentations• Monitor global regulatory trends and assess impact on programs• Collaborate effectively with regional regulatory leads and matrixed teamsQualifications• Bachelor's degree in life sciences required; advanced degree preferred• 5+ years in Regulatory Affairs with global submission experience• 2+ years in Gene Therapy Required• Strong knowledge of global requirements and eCTD formats• Proven ability to manage complex regulatory deliverables• Experience with orphan drug products preferred; inhalation experience a plus• Significant interaction with major global regulatory agencies• Highly organized, detail?oriented, and able to manage tight timelines

Created: 2026-04-15