Job description
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 Overview
The 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 teams
Qualifications
• 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
Role Overview
The 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 teams
Qualifications
• 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