Manager, Regulatory Affairs

Responsibilities

• Manage the planning, compilation, QC, and submission of INDs, BLAs, and amendments
• Prepare routine IND and CTA amendments
• Work with submission authors and reviewers to ensure high-quality, on-schedule documentation
• Provide regulatory expertise to cross-functional teams
• Assist in developing and managing Gantt charts and submission trackers
• Maintain logs of IND and CTA submissions and agency correspondence
• Prepare submission templates and shells based on company standards

Requirements

• BA/BS degree in a related field
• 8+ years of experience in regulatory affairs for drug/biologic development (or 6+ years with a Master's, or 4+ years with a PhD)
• Experience managing regulatory submissions in eCTD format for global health authorities
• Broad understanding of international regulations, ICH, and regional requirements
• Proficiency in Microsoft Office Suite and Adobe Acrobat Pro
• Strong organizational, planning, and interpersonal communication skills

Preferred Qualifications

• Advanced degree in a relevant field

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the human immune system.