Senior Regulatory Affairs CMC Associate

Responsibilities

• Support management of the planning, compilation, QC, and submission of CMC dossier content for clinical and commercial applications
• Prepare and adapt submission documents for global clinical and commercial submissions following eCTD specifications
• Independently plan and prepare routine clinical trial application amendments and commercial submissions
• Manage submission trackers and maintain logs of regulatory correspondence with FDA and other agencies
• Facilitate communication with Vendors and CROs to ensure timely delivery of high-quality IND, CTA, and EU-CTR submissions
• Support the implementation of regulatory strategy for projects from IND through NDA/BLA approval and commercialization
• Create documents in accordance with eCTD specifications

Requirements

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred
• Minimum 8 years of experience in regulatory affairs or related drug/biologic development
• Understanding of US and international regulations (ICH) in drug/biologics development
• Familiarity with ICH eCTD structure and post-approval change requirements
• Advanced skills 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.