Regulatory Affairs CMC Associate II

Responsibilities

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications
• Prepare and adapt submission documents for global clinical and commercial submissions following eCTD specifications
• Independently manage submission trackers and maintain logs of clinical and commercial submissions and correspondence
• 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 5 years of experience in regulatory affairs or a related function in drug/biologic development
• Understanding of US and Ex-US international regulations and procedures in drug/biologics development
• Familiarity with ICH eCTD structure and major market post-approval change requirements
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro
• Excellent written, organizational, and interpersonal communication skills

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.