Manager, Regulatory Affairs CMC

Responsibilities

• Manage planning, compilation, QC, and submission of INDs, BLAs, and amendments
• Prepare routine IND and CTA amendments
• Provide regulatory expertise to cross-functional teams on specified projects
• Interface with Quality Assurance, clinical manufacturing, and commercial manufacturing to maintain change control programs
• Develop CMC regulatory strategy for product changes at all stages of development
• Negotiate with internal stakeholders to ensure alignment with ICH guidelines and country regulations
• Maintain logs of IND and CTA submissions and correspondence with regulatory agencies
• Assist in developing and managing Gantt charts and submission trackers

Requirements

• BA/BS degree in a related field
• At least 8 years of experience in regulatory affairs or drug/biologic development
• Experience managing regulatory submissions in eCTD format for global health authorities
• Broad understanding of international regulations, ICH, and regional requirements
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro
• Strong organizational, planning, and negotiation skills

Preferred Qualifications

• Advanced degree in a related 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 ability of the human immune system to recognize and attack diverse cancer cells.