Senior Regulatory Affairs Specialist

Responsibilities

• Manage submission planning and oversight for IND related activities including Annual reports, Orphan drug reports, and DSUR
• Plan, compile, QC, and submit Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and amendments
• Prepare routine IND and CTA amendments, Investigator Packages, and SUSARs
• Manage Vendors and CROs to ensure high-quality IND, CTA, and EU-CTR submissions are delivered timely
• Support regulatory strategy implementation for projects from IND through NDA/BLA approval and commercialization
• Represent Regulatory Affairs on cross-functional teams and provide regulatory expertise
• Maintain logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies
• Prepare templates, shells, and effective presentations for internal and external audiences

Requirements

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred
• Minimum 8 years of experience in regulatory affairs or related drug/biologic development
• Experience managing regulatory submissions in eCTD format is a plus
• Understanding of US and international regulations (ICH and regional requirements)
• Proficiency in Microsoft Office Suite and Adobe Acrobat Pro
• Strong scientific or research background in pharmacy, chemistry, or biology preferred

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.