Manager, Regulatory Affairs CMC

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Manager, Regulatory Affairs CMC, represents Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role. Essential Functions and Responsibilities Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. Prepares routine IND and CTA amendments. Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program. Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development. Work within the CMC Regulatory Affairs team to gain consensus on proposed changes. Negotiate with internal stake